L0303 VIP Catalog & Manual.pdf

7/23/2019 L0303 VIP Catalog & Manual.pdf

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VIP Catalog & Surgical Manual


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Company Overview

Virtual Implant Placement

VIP

Applications

System Requirements

VIP Components

VIP Software

Pilot Drill Set

Individual Pilot Drill Instruments

Laboratory

Collaterals

Disclaimer

CT Planning

CT Scan Appliance

Compu-QuickCT Scan

CT Scan Protocol

VIP Planning

VIP Interface

DICOM Converter

Draw Nerve

Implant Planning

Submit VIP Treatment Plan for Pilot Compu-Guide

Order Online

Additional Features Measuring Tools

Virtual Teeth

Parallel Implants

Preferences

Compu-Guide

Pilot Compu-Guide

Pilot Drill Set

Important Considerations

Pilot Drill Set Cleaning

Pilot Compu-Guide Pre-Operative

Pilot Compu-Guide Surgical Procedure

Notes

Icon Legend & References

Ordering & Warranty Information

TABLE OF CONTENTS

1

2

3

3

4

4

4

5

6

7

8

99

10

11

12

13

14-15

15

16

17-18

18

19

19

20

21

21

21

22

22

23

24

25



Game-changing Innovation

Unparalleled Service

Science-based products

Our highly advanced implant technologies, Restoration-to-Implant Lifetime

Warranty, hard and soft tissue regeneration products, and cutting-edge digital

dentistry and Virtual Implant Placement (VIP) treatment planning software have

placed BioHorizons at the forefront of implant dentistry.

From surgical planning and site development to final restoration, BioHorizons

is uniquely positioned to streamline the implant and restorative processes,

enabling clinicians to create a more efficient continuum of care.

Happy patients are the driving force of successful dental practices, and clinicians

know they don’t want implants; they want teeth. Restorations made on

BioHorizons implants at select laboratories using an approved treatment planare guaranteed for life. If the prosthesis fails, we cover the cost of the re-work

with no red tape or fine print.

BioHorizons is known for using science and innovation to create unique

implants with proven surgical and esthetic results. Laser-Lok microchannels

exemplify our dedication to evidence-based research and development.

The effectiveness of Laser-Lok has been proven with over 15 years of in vitro,

animal, and human studies at leading universities.1 This patented precision laser

surface treatment is unique within the industry as the only surface treatment

shown to attract a physical connective tissue attachment to a predeterminedzone on the implant while inhibiting epithelial downgrowth and preserving the

coronal level of bone; long term.2



Virtual Implant Placement (VIP) treatment planning software was developed by a team of clinicians with the goal

of providing a user friendly, virtual treatment planning solution that reduces clinical challenges and enhances post

operative outcomes from both a clinical and esthetic perspective. This software provides the following benefits:

VIP provides a simplistic solution where the virtual treatment plan can be transferred to a Pilot Compu-Guide

following the established process flow included in this manual.

VIRTUAL IMPLANT PLACEMENT

VIP

Clinician receives DICOM data from CT Scan site and

prepares a virtual treatment plan using VIPStep 4

If a surgical guide is necessary: CT Scan Appliance, VIP

treatment Plan & Pilot Compu-Guide Prescription form

are sent to the laboratory

Patient wears the CT Scan Appliance during the CT ScanStep 3

Step 5

Clinician performs procedure using the Pilot Compu-Guide

surgical templateStep 6

Laboratory fabricates CT Scan Appliance and returns to

the implant clinicianStep 2

Upper and lower diagnostic casts are sent to the laboratoryStep 1

• Interactive 2 Dimensional (2D) and 3 Dimensional (3D) treatment planning

• Improved case predictability and confidence

• Improved communication between clinician and patient

• Self Processing Digital Imaging and Communications in Medicine (DICOM) converter

• BioHorizons realistic 3D implants

• Open platform implant compatibility



VIP is designed to facilitate 2D and 3D treatment planning for the following clinical applications:

• Partially edentulous single implant placement

• Immediate extraction/single implant placement

• Partially edentulous multiple implant placement

• Fully edentulous multiple implant placement

VIP treatment plans can be used for custom Pilot Compu-Guide fabrication for the following implant

treatment plans:

• Partially edentulous single implant placement

• Immediate extraction/single implant placement

• Partially edentulous multiple implant placement

• Fully edentulous multiple implant placement

It is recommended to install VIP on a stand-alone computer that provides the minimal system requirements.

Minimal System Requirements

Windows® XPOperating system

Pentium® III CPU, 500 MHzProcessor

1 GB of free hard drive disk spaceHard Drive

256 MBInternal memory

15” monitorMonitor

Windows supported mouseMouse

Windows Internet Explorer® 6 and 7Internet

An email application and a mouse with a scroll wheel are recommended.

Applications

System Requirements

VIRTUAL IMPLANT PLACEMENT



products shown not to scale

2.0 x 28mm CGS Pilot Drill

122-028122-017


122-021


122-024


VIP2.1

Interactive 2D and 3D treatment planning software. Includes (2) software licenses.

VIP 2.1 Software

VIPSUG

Upgrade VIP to current software version.

VIP Software Upgrade

122-000

Includes 2.0 x 17, 21, 24, and 28mm Pilot Drills. Pilot Drills are used with the Pilot Compu-Guide

(See Page 20). The Drilling Report that is provided with the Pilot Compu-Guide specifies the Pilot

Drill to be used for the particular implant site.

2.0mm CGS Pilot Drill Set

HF-IMS-1372T

A hollow, rectangular, silicone base with a stainless steel lid that is designed to hold burs securely

in place during cleaning and sterilization.

IMS Bur Cushion - Tall Lid

VIP COMPONENTS

VIP Software

Pilot Drill Set

Individual Pilot Drill Instruments

Individual Pilot Drill replacements for the Pilot Drill Set. The Drilling Report that is provided with the Pilot Compu-Guide specifies the Pilot Drill to be

used for the particular implant site.




*Becden Dental Laboratory offers a full range of laboratory products and services. Becden understands that customer

support and quality assurance are critical to the success of the relationship between the clinician and laboratory.

Becden Dental Laboratory

131 East 13065 South

Draper, Utah 84020

CT Scan Appliance

Custom fabricated radiographic guide that is worn by the patient during the

CT Scan. Radiopaque teeth are used where implant therapy is indicated.

Compu-Quick

Pre-fabricated CT Scan Appliance reducing time required to custom fabricate a

CT Scan Appliance. The Compu-Quick is available in three sizes: B, C, and D.

Pilot Compu-GuideSurgical template that is custom milled according to the submitted VIP treatment

plan. The Pilot Compu-Guide provides the initial 2mm osteotomy for implant

location, depth, and angulation.

Laboratory components relating to VIP are fabricated / distributed by Becden Dental Laboratory*. Becden is part

of Dental Technologies Inc. (DTI) laboratory network that is focused on providing innovative laboratory technologies

and exceptional customer service.

Toll free: 888.344.9991

Fax: 801.576.9994

Website: www.becdendti.com

Email: [email protected]

Laboratory

VIP COMPONENTS




ML0131

MLD101

Pilot Compu-Guide Prescription Form

PatientName/Unique Identifier:

DoctorName:

AddressLine 1:

AddressLine 2:

Email:

Specialty:

Phone:

Fax:

Office Contact:

Page 1of 1

FORMB1046 REV B DEC 2008

IncludedCTScanAppliance orCompu-Quick

1)CustomerInformation

2)PilotCompu-GuideInstructions

P le as e i nd ic at e a rc h: M an di bl e M ax il la

Pleaseuseaseparateprescription formfor each arch

Case Notes(RestorationGoals):

3)PrescriptionForm Signature

I acknowledgeresponsibilityfor thispatient’sVIP dental implantposition, treatmentplan andsurgical placementofdental implants.

Doctor Name (Print) License Number

Toensuretimelyreturn ofCompu-Guide, pleasemakesuretoinclude:

PleaseCompletePilotCompu-GuideContentsChecklist

VIPTreatmentPlansavedtoCD oremailed

CTScanDICOMImages(recommended)

ExpectedDate of Appointment:

UpperandLowerDiagnosticCasts(requiredforCompu-Quickcases)

CompletedPilotCompu-Guide PrescriptionForm

DoctorName (Signature) Date

4)ContentsChecklist

131 East13065 South

Draper, UT 84020

888.344.9991

www.becdendti.com

CentricRecord(requiredforCompu-Quickcases)

CT Scanning Protocol

Scanthe patientface uporforwardandmake surethe patient’sheadis nottiltedtoeither side.Whenscanningsingle jaws(mandible ormaxilla),orientthepatient’sheadso thattheaxialimages are paralleltothe occlusalplane of the radiopaque

teethonthe patient’sCTScanAppliance.Whenscanningdoublejaws(mandibleandmaxilla), splitthe differencebetweenthe occlusalplanesof the jaws.If noCTScanApplianceisavailable, separate archeswitha bite block.

Fiducialmarkers(3markers onCTScanAppliance) are criticaltothe PilotCompu-Guide fabricationprocess.Scanatleast

2mmbeyondthe tipsof the fiducialmarkers,ensuring all3fiducial markersappearinthe scan. Ensure sure thatthe fieldof view includesallteethand allfiducialmarkers.

Itisimportantthat allscansare reviewedforpatientmovementpriortosubmission.Scansthati ndicate patientmovement

shouldnotbe usedfortreatmentplanningpurposes.

• I m ag e s i ze 5 12 x 5 12 p i xe l s

• G an try t il t 0.0degrees( requ ired)

• S cann ersl icethickn ess 0.5- 1.0mm

• S cann erstepincremen t 0.5- 1.0mm

• R ec on st ru ct io n al g or i th m B on e

• Recon structedsl ice th ickn ess 0.5- 1.0mm

• Reconstructedslice spacing 0.5- 1.0mm

• S c ou t i ma g e O p ti o na l

• Fieldof View (FOV) Typically 150-180mm.

• Format DICOM3.0data withDICOMDIR. Axialsandoptionalscout(s) only.

• C ompression Non e

• Media C D-RorZipdisk .

Maxilla Mandible Both arches, cone beam

PreferredScanningParameters

PatientOrientation

Page 1of 1

131 East13065 South

Draper, UT 84020

888.344.9991

www.becdendti.com


SurgicalNotes:

FORMB1047 REV A SEP 2008

Standardcase:

2)CT ScanApplianceInstructions

Please in d icatearch : M an dib le M ax il la


Thefollowing teethare beingreplaced(please listteethbelow andindicate indiagram)



Doctor Name (Print) License Nu mber

Partially edentulouscase:

Completely edentulouscase:

Toensuretimelyreturn ofCTScan Appliance, pleaseinclude:

Centricrecord

PleaseCompleteCT ScanApplianceContentsChecklist

DoctorName(Signature) Date

Upperandlowerdiagnosticcasts

An im pres s ion with th e provis ional in p lace An im pres s ion with th e prov is ion alrem oved

Anacrylicduplicationof the denture

4)ContentsChecklist

CT Scan Appliance Prescription Form

PatientName/UniqueIdentifier:

DoctorName:

AddressLine 1:

AddressLine 2:

Email:

Specialty:

Phone:

Fax:

Office Contact:

Page 1of 1


131 East13065 South

Draper, UT 84020

888.344.9991

www.becdendti.com

ML0129

ML0114

ML0103

FORM B1055

FORM B1047

FORM B1046

Patient Education – Stabilizing dentures using dental implants

Patient Education – Rebuilding and maintaining bone

Patient Education – Soft tissue grafting with AlloDerm

Patient Education – Tooth replacement with dental implants


Used to provide the CT Scan site to ensure the patient is scanned according

to the parameters required by VIP. Additional forms can be downloaded

from Becden’s website.


Used to provide case specific information to the laboratory concerning

the custom fabrication of the CT Scan Appliance. The form must be

completed in its entirety and signed by the clinician. Additional forms canbe downloaded from Becden’s website.


Used to provide case specific information to the laboratory concerning the

custom milling of the Pilot Compu-Guide. The form must be completed in

its entirety and signed by the clinician. Additional forms can be downloaded

from Becden’s website.

Patient Education – Dental Implants - the tooth replacement solution

This high-quality flipbook helps the implant candidate understand the rationale

and the advantages of implant therapy compared to traditional treatment

methods. 9” x 6” (23cm x 16cm).

COLLATERALS



This Surgical Manual serves as a reference for using the Virtual Implant Placement (VIP) treatment planning software, CT

Scan Appliance, Pilot Compu-Guide, and related surgical instrumentation. It is intended solely to provide instructions on

the use of BioHorizons products. It is not intended to describe the methods or procedures for diagnosis, or placement of

implants, nor does it replace clinical training or a clinician’s best judgment regarding the needs of each patient. BioHorizons

strongly recommends appropriate training as a prerequisite for the placement of implants and associated treatment.

The procedures illustrated and described within this manual reflect idealized patient presentations with adequate bone

and soft tissue to accommodate implant placement. No attempt has been made to cover the wide range of actual patient

conditions that may adversely affect surgical and prosthetic outcomes. Clinician judgment as related to any specific

case must always supersede any recommendations made in this or any BioHorizons literature.

Before beginning any implant surgical procedure with BioHorizons products:

• Read and understand the Instructions for Use that accompany the products.

• Clean and sterilize the instruments per appropriate Instructions for Use.

• Become thoroughly familiar with all instruments and their uses.

• Design a surgical treatment plan to satisfy the prosthetic requirements of the case.

Treatment Planning

For ideal results in implant dentistry, the treatment team should be in agreement and in communication throughout all

stages of therapy. The patient, the restorative and surgical doctors, as well as the dental laborator y should understand and

agree upon the treatment plan. The treatment plan should determine the design, number and position of the implants.

DISCLAIMER

Proper treatment planning using VIP is the responsibility of the medical professional. Each clinician must

evaluate the appropriateness of the virtual treatment plan and the procedure used based on personal medical

training and experience.

Use of VIP to pre-plan dental implant surgery requires an understanding of the software. Refer to VIP’s Help

Manual which is located within the VIP software (Help > Help Index).




When the CT Scan Appliance is returned the appliance should be inserted into the patient’s mouth to ensure proper fit. The

CT Scan Appliance should also be visually inspected to ensure the appliance complies with the submitted prescription form.

Bite blocks are fabricated on the CT Scan Appliance to ensure adequate space between arches.

Fiducial marker

CT Scan Appliance

CT PLANNING

• Custom fabricated to patient’s tooth anatomy

• Radiopaque material used to indicate edentulous space

• Fabricated by Becden Dental Laboratory

Purpose: Radiographic guide that provides visualization in the CT scan of

optimal implant placement and prosthetic outcome.

The CT Scan Appliance Prescription Form must be completed in order for the

laboratory to fabricate the CT Scan Appliance. Complete the Contents Checklist

included on the form to ensure all necessary components are sent to the laboratory.

The requirements for fabrication of a CT Scan Appliance include:

The CT Scan Appliance includes three Fiducial Markers that act as coordinates in

transferring the VIP treatment plan to the Pilot Compu-Guide. All three Fiducial

Markers must be visible in the CT Scan in order for a Pilot Compu-Guide to be

fabricated. Reference the CT Scanning Protocol for scanning requirements. (See

Page 10 for CT Scan Protocol).

Confirm unique fitto patient’s mouth.

If unique fit cannot be confirmed,the appliance should not be used

for the CT Scan.

SurgicalNotes:

FORMB1047 REV A SEP 2008

Standardcase:

2)CT ScanApplianceInstructions

Please in d icate arc h : M an dib le M ax il la


The following teethare being replaced(please listteeth below andindicate indiagram)



Doctor Name (Print) License Nu mber

Partially edentulouscase:

Completely edentulouscase:

Toensuretimelyreturn ofCTScan Appliance,pleaseinclude:

Centricrecord

PleaseCompleteCT ScanApplianceContentsChecklist


Upperandlowerdiagnosticcasts

An im pres s ion with th e provis ional in p lace An im pres s ion with th e provis ionalrem ov ed

Anacrylicduplicationof the denture

4)ContentsChecklist



DoctorName:

AddressLine 1:

AddressLine 2:

Email:

Specialty:

Phone:

Fax:

Office Contact:

Page 1of 1


131 East13065 South

Draper, UT 84020

888.344.9991

www.becdendti.com

• Upper and lower diagnostic cast

• Partially edentulous case:

- Impression with the provisional in place

- Impression with the provisional removed

• Completely edentulous case:

- Acrylic duplication of the denture

• Completed and signed CT Scan Appliance Prescription Form




The tray should be lined with rigid bite registration material and then

placed on the appropriate arch to have the bite registration applied to

the Compu-Quick. The patient then wears the Compu-Quick during

the CT Scan rather than the pre fabricated CT Scan Appliance. (See

Page 10 for CT Scan Protocol).

An appointment should be scheduled to have the CT scan performed.

If the scan is offsite then the patient should be instructed as how to

properly wear the CT Scan Appliance or Compu-Quick. The CT Scanning

Protocol should be provided to the scan site to ensure proper scan.

Upon completion of the CT Scan a CD will be provided containing

DICOM data images from the CT Scan. The DICOM images can then beloaded directly into VIP for virtual implant treatment planning.

CT PLANNING

• Reduces time for custom fabrication of CT Scan Appliance

Purpose: Prefabricated CT Scan Appliance that is only indicated for

placement of three implants or less to be placed in a non-esthetic area.

Purpose: Instructs scanning site how to properly scan patient.

Compu-Quick

CT Scan

The Pilot Compu-Guide Prescription Form must be completed in

order for the laboratory to fabricate the Pilot Compu-Guide. The

requirements for fabrication of a Pilot Compu-Guide include:


Scanthe patientface uporforwardand make sure the patient’sheadisnottilted toeitherside.When scanning single jaws

(mandible ormaxilla),orientthe patient’sheadsothatthe axiali magesare paralleltothe occlusalplane of the radiopaqueteethonthe patient’sCTScanAppliance.Whenscanning double jaws(mandible andmaxilla),split the difference betweenthe occlusalplanesof the jaws.If noCTScanAppliance isavailable,separate archeswitha bite block.

Fiducialmarkers(3markerson CTScanAppliance) are criticaltothe PilotCompu-Guide fabricationprocess.Scanat least2mmbeyondthe tipsof the fiducialmarkers,ensuring all3fiducial markersappearinthe scan. Ensure sure thatthe fieldof viewincludesall teethandallfiducial markers.

Itisimportantthatall scansare reviewedforpatientmovementpriorto submission.Scansthatindicate patientmovementshouldnotbe usedfortreatmentplanning purposes.

• Image size 512x512pixel s

• G an try t il t 0.0degrees( required)

• S cann ersl ice th ickn ess 0.5-1.0mm

• S cann erstepin crement 0.5-1.0mm

• R ec on st ru ct io n al go ri th m B on e

• Recon structedsl ice th ickn ess 0.5-1.0mm

• Reconstructedslice spacing 0.5-1.0mm

• S coutimage Option al

• Fieldof View (FOV) Typically 150-180mm.

• Format DICOM3.0data withDICOMDIR.

Axialsandoptionalscout(s) only.• C ompression Non e

• Media C D-RorZipdisk .

Maxilla Mandible Both arches, cone beam

PreferredScanningParameters

PatientOrientation

Page 1of 1

131 East13065 South

Draper, UT 84020

888.344.9991

www.becdendti.com


• Compu-Quick

• VIP treatment plan (via email or CD)

• Upper and lower diagnostic cast

• CT Scan DICOM images (recommended)

• Completed and signed Pilot Compu-Guide Prescription FormVIP includes virtual teeth that can be placed in

the desired tooth position since a radiopaque

scan appliance was not used to note the

edentulous location.



The patient will be scanned wearing either the pre-fabricated CT Scan Appliance or the Compu-Quick. If a Pilot Compu-

Guide surgical template is not desired then the scan should be completed with a minimum space between arches of 5mm.

The CT Scan Appliance or Compu-Quick should be inserted in the patient’s mouth while ensuring proper fit. The patient

should be scanned face up or forward and the patient’s head should not be tilted to either side.

For Single jaw scans the patient’s head should be oriented so that the axial images are parallel to the occlusal plane of the

radiopaque teeth on the patient’s intraoral appliance. For double jaw scans, split the difference between the occlusal planes

of the jaws.

The three Fiducial Markers must appear in the scan in their entireties. Scan at least 2mm beyond the tips of all three Fiducial

Markers. Make sure that the field of view includes all teeth and all Fiducial Markers. Load the case after processing to verify

that all three markers are completely visible.

Maxilla Mandible

CT PLANNING

Both arches: cone beam

Preferred Scanning Parameters

Image size

Gantry tilt

Scanner slice thickness

Scanner step increment

Reconstruction algorithm

Reconstructed slice thickness

Reconstructed slice spacing

Scout image

Field of View (FOV)

Format

Compression

Media

512 x 512 pixels

0.0 degrees (required)

0.5 - 1.0 mm

0.5 - 1.0 mm

Bone

0.5 - 1.0 mm

0.5 - 1.0 mm

Optional

Typically 150-180 mm.

DICOM 3.0 data with DICOMDIR. Axials and optional scout(s) only.

None

CD-R or Zip disk.

CT Scan Protocol



Installation of VIP is a demo version until a software license is requested and applied. The software license can

be requested via Internet connection by navigating to Tools > License and submitting the requested information.

Customer Care can also assist with providing a software license for VIP.

VIP’s user friendly interface simplifies the process of virtually treatment planning a case. The screen layout has four

options to provide the user with the preferred layout. VIP’s default screen layout is divided into four sections which

includes: panoramic projection, panoramic, axial, and cross section view.

VIP PLANNING

VIP Interface

Screen layout 2 includes cross section,

axial, and panoramic view.

Screen layout 3 includes cross

section, 3D, and panoramic view.

Screen layout 4 includes axial, 3D,

cross section, and panoramic view.

The Panoramic projection view displays the CT Scan as it would look as an X-ray. This view is only for

interpretation and cannot be changed or modified.

Reference the VIP User’s Manual in the software for more detailed instructions (Help > Help Index ).

Preferred screen layout can be selected by navigating to Tools > Preferences. Select the Layout tab in the Preferences

Dialog box and enable the preferred layout by selecting the Apply button. If the layout is changed, the selected layout

will display the next time VIP is opened.



After selecting the jaw type, unnecessary slices need to be

removed from the view. When removing unnecessary slices use

the left-click mouse button to select Make most superior and

Make most inferior.

Select File > Process or click the Process button located on

the toolbar. VIP will open the default DICOM directory. Choose the

desired case and select the Finish button.

VIP PLANNING

DICOM Converter

Choose the most favorable image of the arch at the level of the

apical root tips. In the Axial View the panoramic curve must be

drawn according to the patient’s jaw alignment.

• Eliminates potential fees related to processing of DICOM files

• Reduces time related to having DICOM files processed offsite

Purpose: Convert DICOM images from CT Scan into a format that

can be viewed by VIP.

Mandible - Inferior position = ~bottom tip of chin

- Superior position = ~2mm above Fiducial Markers

- Inferior position = ~2mm below Fiducial Markers

- Superior position = ~midway in the sinus

Maxilla



Select Tools > Edit Nerve or click the Edit Nerve button located on the toolbar. The Edit Nerve Dialog box will

appear. Nerve can be drawn according the patient’s nerve canal. In the panoramic or cross section view, Left-click

within the nerve canal to connect the points that indicate the nerve canal. After drawing the nerve in the panoramic view

the nerve will be displayed in the panoramic, axial, cross section, and 3D view.

VIP PLANNING

Draw Nerve

• Enhances view of nerve canal

• Assist in placement and selection of implants

• Nerve can only be highlighted in the mandible

Purpose: Highlight inferior alveolar nerve to make more visible.

In order to draw a second nerve, select the New button in the Edit Nerve Dialog box. Exit the Edit Nerve Dialog box once

nerve has been drawn.



To place an implant, choose the Implant button and then left-click on the axial, panoramic, or cross sectional view.

The implant will be placed centered on the position selected. After the implant is placed, right-click the implant and select

Choose Implant to place the preferred type of implant. Implants can be manipulated by moving the implant and/or

rotating the implant. Additional implants can be placed by repeating steps.

VIP PLANNING

Implant Planning

Placing the cursor in the preferred image and pressing the

spacebar will expand the image. Pressing the spacebar

again will return the image to its original view.

• Comprehensive implant library that is compatible with most implant systems

• BioHorizons implants are displayed as 3D realistic implants

• Planning report created from treatment plan

Purpose: Pre-plan implant procedure through the placement of implants.



VIP PLANNING

Implant Planning

VIP provides a 3D view of the implant placement and anatomical

structure. To view 3D select the 3D button or View > 3D.

The view includes options of viewing the bone, teeth, implants, and

virtual teeth.

A Pre-surgical Implant Planning Report can be printed by navigating to

File > Print Report. The report includes the following information:

Submit VIP Treatment Plan for Pilot Compu-Guide

Select Transfer on the VIP menu and either choose Create CD or

Send via E-mail. After selecting option, the VIP Disclaimer Dialog

box will appear, read the disclaimer and choose I Accept or I do not

Accept. If I Accept is selected the case will proceed to be transferred

via email or by CD.

• Treatment plan can be submitted via email or copying files to CD

Purpose: Submit plan to laboratory for fabrication of Pilot Compu-Guide

The Pilot Compu-Guide Prescription Form must be completed in

order for the laboratory to fabricate the Pilot Compu-Guide. (See

page 20 for Pilot Compu-Guide requirements).

• Patient information

• Implant manufacturer

• Implant size

• Screenshots of the axial, panoramic, and cross section view

Images include implant placement and the illustrated nerve. The

Planning Report can be printed to a printer or PDF for viewing.

VIP Pre-surgica l Implant Planning Report

Prepared with Virtual Implant Placement (VIP) Software fromBioHorizonsImplant Systems, Inc.

StudyDate: 20010101

Clinician:SMITH

Patient:Head,Fred

Sex: M

Age: 060Y

ID: 12345

Jaw: MANDIBLE

List of Implants

Implant Length Diameter Manufacturer Line Model

12.00 4.60/3.10 BioHorizons Tapered TLR4612

9.00 3.50 BioHorizons Internal LPYR3509

VIP Pre-surgica l Implant Planning Report

Prepared with Virtual Implant Placement (VIP) Software fromBioHorizonsImplant Systems, Inc.

StudyDate: 20010101

Clinician:SMITH

Patient:Head,Fred

Sex: M

Age: 060Y

ID: 12345

Jaw: MANDIBLE

List of Implants

Implant Length Diameter Manufacturer Line Model

12.00 4.60/3.10 BioHorizons Tapered TLR4612

9.00 3.50 BioHorizons Internal LPYR3509



VIP PLANNING

Order Online

• Secure online ordering of BioHorizons implants

• BioHorizons implants used in treatment plan are captured in online Shopping Cart

Purpose: Order online BioHorizons implants used in treatment plan.

Implants placed in the treatment plan can be reviewed in the Implant

List.

To view the Implant List and place BioHorizons implant order online,

select View > Implant List or click the Implant List button .

If BioHorizons implants are not included in the Implant List then the

option to order online will be disabled. To order online select the

BioHorizons Order On-line button.

Upon logging in, the BioHorizons implants used in the VIP treatment

plan are placed in the Shopping Cart.

After selecting Order Online, BioHorizons Online Catalog will

prompt for username and password. If not a current BioHorizons

customer or a customer account is not activated; follow the

prompts on the login screen.

Guest access to BioHorizons Online Catalog allows access to viewthe catalog without placing an order.



ADDITIONAL FEATURES

Measuring Tools

• Measurements can be made in the panoramic, axial, and cross section view

• ROI illustrates Hounsfield Units

Purpose: Utilize measuring tools to measure distance, angle, and rectangular / elliptical Region of Interest (ROI).

To measure linear distance, select Tools > Distance or click the Distance button

located on the toolbar. Once image is selected for measuring, left-drag either

end of the measurement tool to obtain linear distance. The linear distance default

measurement is millimeters, however can be changed to centimeters or inches by

right-clicking the display box and selecting preferred unit.

To measure an angle, select Tools > Angle or click the Angle button located

on the toolbar. Left-drag the vertex or either end of the angle tool to obtain the

measurement of the angle. The angle measurement is displayed in degrees.



ADDITIONAL FEATURES

Virtual Teeth

To measure the elliptical ROI, select Tools > Elliptical ROI or click the Elliptical ROI

button located on the toolbar. Left-drag the corners or sides of the oval to

adjust the ROI. The elliptical ROI displays the area of patient anatomy covered by theregion, the average and standard deviation of the pixel data in Hounsfield units.

Measuring Tools

To measure the rectangular ROI, select Tools > Rectangular ROI or click the

Rectangular ROI button located on the toolbar. Left-drag the corners or sides

of the rectangle to adjust the ROI. The rectangular ROI displays the area of patient

anatomy covered by the region, the average and standard deviation of the pixel data

in Hounsfield units.

• Assists in treatment planning when Compu-Quick is used for CT Scan

Purpose: Simulate teeth to facilitate positioning of implants.

To place Virtual teeth, click the Place Tooth button .

Select the appropriate teeth in the Place Virtual Tooth Dialog Box.

After the Virtual Tooth is placed, right-click the tooth for additional

properties related to the tooth. Virtual Teeth can be manipulated

by moving the virtual teeth and/or rotating the virtual teeth. The

Dialog box must be open in order to move or rotate virtual teeth.

VIP comes equipped with a full set of Virtual Teeth which can be

placed to facilitate the positioning of implants in cases where no

custom scan appliance is desired.



ADDITIONAL FEATURES

Parallel Implants

Preferences

The Implant List Dialog Box must be open to parallel two or more

implants. Select View > Implant List or click the Implant List

button . Select the target implant in the Parallel To to which all

other implants will be parallel. After selecting the target implant,

hold the CTRL key and select implants to be placed in parallel

to the target implant. Then select the Parallel button to parallel

selected implants.

• Parallel implants to selected target implant

Purpose: Parallel two or more implants.

Select Tools > Preferences for the Preferences Dialog box to open.

Preferences can be enabled according to preferred user settings.

The Preferences Dialog Box includes the following tabs:

Purpose: Enable user preferences within VIP.

• 3D

• Cases

• Colors

• Display

• Layouts

• Paths

• Reformatting




The Pilot Compu-Guide provides the initial 2mm pilot osteotomy for implant location,

depth, and angulation. The surgical template is accompanied by a Drilling Report

indicating the appropriate Pilot Drill to be used for each implant location.

The Pilot Compu-Guide Prescription Form must be completed in order for the

laboratory to fabricate the Pilot Compu-Guide. Complete the Contents Checklistincluded on the form to ensure all necessary components are sent to the laboratory.

The requirements for fabrication of a Pilot Compu-Guide include:

• Tooth supported surgical template

• Provides initial 2mm pilot osteotomy

• Fabricated by Becden Dental Laboratory

Purpose: Transfers virtual treatment plan to a surgical template for implant location,

depth, and angulation.

COMPU-GUIDE

Pilot Compu-Guide

• CT Scan Appliance or Compu-Quick

• VIP treatment plan (via email or CD)

• Upper and lower diagnostic cast (required for Compu-Quick cases)

• CT Scan DICOM images (recommended)

• Completed and signed Pilot Compu-Guide Prescription Form

The Pilot Compu-Guide transfers the VIP treatment plan to the patient’s mouth for implant location, angle and depth.

After performing the initial 2mm pilot osteotomy according to the Drilling Report, the implants should be placed

according to the implant manufacturer’s protocol.



DoctorName:

AddressLine 1:

AddressLine 2:

Email:

Specialty:

Phone:

Fax:

Office Contact:

Page 1of 1


IncludedCTScanAppliance orCompu-Quick


2)PilotCompu-GuideInstructions

P le as e i nd ic at e a rc h: M an di bl e M ax il la


Case Notes(RestorationGoals):


I acknowledgeresponsibilityfor thispatient’sVIP dental implantposition,treatmentplan and surgical placementofdental implants.

Doctor Name (Print) License Number

Toensuretimelyreturn ofCompu-Guide, pleasemakesuretoinclude:

PleaseCompletePilotCompu-GuideContentsChecklist

VIPTreatmentPlansavedtoCD oremailed

CTScanDICOMImages(recommended)

ExpectedDate of Appointment:

UpperandLowerDiagnosticCasts(requiredforCompu-Quickcases)

CompletedPilotCompu-Guide PrescriptionForm


4)ContentsChecklist

131 East13065 South

Draper, UT 84020

888.344.9991

www.becdendti.com

CentricRecord(requiredforCompu-Quickcases)

VIP treatment plan is

transferred to the Pilot

Compu-Guide.

Initial 2mm pilot

osteotomy is created

using the appropriate

Pilot Drill as indicated in

the Drilling Report.




COMPU-GUIDE

122-017

17mm

21mm

24mm

28mm

122-021 122-024 122-028

• Fixed circular ring acts as a definitive drill stop

• Osteotomy to desired depth

Purpose: Initiates osteotomy using the Pilot Compu-Guide.

Peri-operative oral rinses with a 0.12% Chlorhexidine Digluconate solution have been shown to significantly lower the

incidence of post-implantation infectious complications.3 A preoperative 30-second rinse is recommended, followed by

twice daily rinses for two weeks following surgery.

Drilling must be done under a constant stream of sterile irrigation. A pumping motion should be employed to prevent over-

heating the bone. Surgical drills and taps should be replaced when they are worn, dull, corroded or in any way compromised.

BioHorizons recommends the replacement of drills after 12 to 20 osteotomies.4

The Pilot Drill Set includes four Pilot Drills in varying

lengths that provide implant depth for the initial 2mm pilot

osteotomy. The Drilling Report that is accompanied with the

Pilot Compu-Guide indicates the appropriate drill to be used

per implant site.

The Pilot Drill Set is provided non-sterile and must be cleaned and sterilized prior to use following the associated Instructions

for Use. Always remove instruments from packaging prior to sterilization, and remove and discard packaging materials used to

stabilize and secure instruments during shipment. Double-check all surgical instruments to ensure their functionality prior to

surgery. Backup sterile drills are also recommended.

Caution: The use of hydrogen peroxide or other oxidizing agents will cause damage to the surface of the

instruments. Towel- or air-dry all instrumentation before sterilizing. Drills and taps should be replaced whenwear is noticed, such as a decrease in cutting efficiency or when signs of discoloration appear. Drills should

be replaced after approximately 12 to 20 osteotomy cycles, depending on the bone density.4

Proper testing, cleaning and calibration of sterilization equipment should occur frequently to assure that the units are in proper

working order. Equipment operating conditions vary and it is the responsibility of each dental office to ensure that the proper

sterilization technique for instrumentation is followed.

Pilot Drill Set

Important Considerations

Pilot Drill Set Cleaning




After confirming proper fit visually verify the location of the Pilot drill sleeves, which are positioned according to the

VIP treatment plan. The pi lot dr ill sleeves transfer the VIP treatment plan; therefore it is essential to visually confirm

pre-operative that the Pilot Compu-Guide aligns with the VIP treatment plan. After visually inspecting, place the

Pilot Compu-Guide into the patient’s mouth and ensure the surgical template is stabilized with a unique fit to the

patient’s teeth. If a unique and stable fit of the Pilot Compu-Guide cannot be obtained at time of procedure then the

Pilot Compu-Guide should not be used for the procedure. It is not necessary to use excessive force to seat the Pilot

Compu-Guide.

COMPU-GUIDE

The Pilot Compu-Guide can be used for Flapless surgical technique or conventional surgical technique. Surgical

technique is based upon the clinician’s clinical decision.

After selecting the indicated drill length ensure that the Pilot Compu-Guide is stabilized to prevent any surgical

template movement while drilling. The indicated Pilot Drill will provide the implant location, depth, and angulation

for the 2mm pilot osteotomy. Once all pilot osteotomies have been drilled to the indicated length, remove the Pilot

Compu-Guide.

The implants should be placed according to the implant manufacturer’s protocol.

Pilot Compu-Guide Pre-Operative

Pilot Compu-Guide Surgical Procedure

Visually inspect location

of pilot sleeves.

The Pilot Compu-Guide should

have a unique fit to the patient’s

mouth. If unique fit cannot be

confirmed, the template should

not be used for the procedure.

The Pilot Compu-Guideshould be stabilized

prior to drilling.

The Pilot Compu-Guideis removed and implants

are placed per the

manufacturer’s protocol.



NOTES



Symbol Descriptions for Product Labeling

References

ICON LEGEND & REFERENCES

1. References Available

2. Human Histologic Evidence of a Connective Tissue Attachment to a Dental Implant.

M Nevins, ML Nevins, M Camelo, JL Boyesen, DM Kim.

International Journal of Periodontics & Restorative Dentistry. Vol. 28, No. 2, 2008.

3. The influence of 0.12 percent chlorhexidine digluconate rinses on the incidence of infectious complications and implant success.

Lambert PM, Morris HF, Ochi S.

J Oral Maxillofac Surg 1997;55(12 supplement 5):25-30.

4. Heat production by 3 implant drill systems after repeated drilling and sterilization.

Chacon GE, Bower DL, Larsen PE, McGlumphy EA, Beck FM.

J Oral Maxillofac Surg. 2006 Feb;64(2):265-9.

B i r m i n g h a m , A L 3 5 2 4 4

LOT

REF

VIP 2.1 Softwar e

VIP 2.1

YYXXXXX

Reference/article number

REF

Lot/batch number LOT

No n -S t er i l e

LVIP 2.1 Rev A



BioHorizons No Exceptions Warranty:

Our warranty policies are a tangible expression of our belief in the excellence and simplicity of our products, as well as our commitment

to our customers. We will repair or replace any of our products if they fail or cause problems within the warranty period for any reason,

without exception.

Warranties on Instruments, Surgical Drills, and Virtual Implant Placement (VIP) software:

BioHorizons warranties instruments, surgical drills, and VIP for the period specified for each in (1) and (2) below. During the specified

warranty period we will replace or repair any product with a defect in material or workmanship.

(1) The warranty on BioHorizons instruments extends for a period of one (1) year from the date of initial invoice.

The warranty on BioHorizons Pilot Drills extends for a period of ninety (90) days from the date of initial invoice.

Pilot Drills should be replaced when they are worn, dull, corroded or in any way compromised. BioHorizons

recommends the replacement of drills after 12 to 20 osteotomies.4

(2) The warranty on BioHorizons VIP treatment planning software extends for a period of ninety (90) days from

the date of initial invoice. The warranty requires that VIP be used according to the minimal system requirements.

Return Policy:

Instructions for initiating returns can be found on the reverse side of the invoice that was shipped with the product. Please contact

Customer Care if you need a copy of the instructions or if you have additional questions or requests.

Disclaimer of Liability

This literature serves as reference for Virtual Implant Placement (VIP) treatment planning software, instrumentation, CT Scan Appliance

and Pilot Compu Guide. It is not intended to describe the methods or procedures for diagnosis or placement of implants; nor

does it replace cl inical training or a clinician’s best judgment regarding the needs of each patient. BioHorizons strongly recommends

completion of postgraduate dental implant education and strict adherence to the Instructions for Use (IFU) that is included in the

VIP software.

Treatment planning and clinical application of our products are the responsibility of each individual clinician. BioHorizons is not

responsible for incidental or consequential damages or liability relating to use of our products alone or in combination with other

products other than replacement or repair under our warranties. VIP may only be used in conjunction with the associated original

components and instruments according to Instructions for Use.

Validity

BioHorizons continually strives to improve its products and therefore reserves the right to improve, modify, change specifications or

discontinue products at any time. Upon its release, this literature supersedes all previously published versions.

AvailabilityNot all products shown or described in this literature are available in all countries.

Product Support Specialist:

Cell phone:

Fax:



w w w . b i o h o r i z o n s . c o m

BioHorizons products are cleared for sale in the European Union under the EU Medical Device Directive 93/42/EEC. We are proud to be registered to

ISO 13485:2003, the international quality management system standard for medical devices, which supports and maintains our product licences with

Health Canada and in other markets around the globe.

Original language is English. © 2008 BioHorizons Implant Systems, Inc. All Rights Reserved. L0303 REV A DEC 2008

BioHorizons Canada21 Amber Street, Unit # 6

Markham, Ontario L3R 4Z3

Customer Care / Service à la Clientèle:866-468-8338 or / ou 905-944-1700

BioHorizons SpainSerrano Anguita, 10

28004 Madrid, España

Atención al Cliente:

+34 91 713 10 84

BioHorizons GermanyMarktplatz 3

79199 Kirchzarten

Kunden Service:

+49 7661-909989-0

BioHorizons ChileCerro Colorado 5030, Officina 513

Las Condes

Santiago, Chile

Atención al Cliente:

+56 2 361 9519

BioHorizons MexicoKelvin 8 Dept. 303

Col. Anzures

C.P. 11590, Mexico, D.F.

Servicio al Cliente:

+52 55 5545 1297

BioHorizons Australia25-33 Allen Street

Waterloo NSW 2012

Customer Service:

+61 2 8399 1520

BioHorizons UK 17 Wellington Business Park

Dukes Ride

Crowthorne, Berkshire RG45 6LS

Customer Care:

+44 8700 620 550

BioHorizons USA 2300 Riverchase Center

Birmingham, AL 35244

Customer Care / Servicio al Cliente:888-246-8338 or 205-967-7880

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