CREODENT SOLIDEX CUSTOM ABUTMENT

K113738 · Creodent Prosthetics, Ltd. · NHA · Sep 17, 2013 · Dental

Device Facts

• Record ID: K113738
• Device Name: CREODENT SOLIDEX CUSTOM ABUTMENT
• Applicant: Creodent Prosthetics, Ltd.
• Product Code: NHA · Dental
• Decision Date: Sep 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following: Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants . Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants . Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants

Device Story

Solidex® Customized Abutment; patient-specific prosthetic component; connects to endosseous dental implants to support cemented or screw-retained restorations. Fabricated from titanium; secured to implant via abutment screw. Used by dentists in clinical settings for prosthetic rehabilitation. Design customized to patient-specific requirements. Provides mechanical support for dental prostheses; restores function/aesthetics for edentulous patients.

Clinical Evidence

No clinical data. Bench testing only. Static and fatigue testing conducted per ISO 14801:2007E to evaluate mechanical strength and connection integrity under worst-case scenarios for the specified implant platforms.

Technological Characteristics

Abutment: CP Ti Gr4 unalloyed titanium (ASTM F67/Gr 04-06). Abutment Screw: Ti-6Al-4V Eli titanium alloy (ASTM F-136). Mechanical connection to endosseous implants. Angulations up to 20 degrees from implant axis. Patient-specific geometry.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple-unit prosthetic restorations supported by endosseous dental implants. Compatible with specific Nobel Biocare and Zimmer implant systems.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• Nobel TDS Abutment for Nobel Biocare Replace and Abutment Screw (K091026)
• Nobel Procera Ti Abutment and Abutment Screw (K091756)
• Zimmer Patient-Specific Abutment, Internal Hex Titanium and Abutment Screw (K071439)

Reference Devices

• Nobel Replace™ TiUnite Endosseous Implants (K023113)
• Nobel Active™ Internal Connection Implants (K071370)
• Zimmer Screw-Vent / Tapered Screw-Vent Implants (K013227)

Submission Summary (Full Text)

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KI13738

Premarket Notification Section 5: Page - 4

### 510(k) Summarv

### CreoDent Prosthetics, Ltd. Solidex® Customized Abutment

SEP 17 2013

#### Submitter Information

Company Name: Company Address:

Company Telephone: Company Fax: Contact Person:

CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, New York 10001 [phone] [phone] Calvin Shim [phone] July 27, 2012

Date Summary Prepared:

### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name:

Product Code: Classification Panel: Reviewing Branch:

CreoDent Solidex® Customized Abutment Endosseous Dental Implant Abutment. 21 CFR 872,3630 NHA Dental Products Panel Dental Devices Branch

# INDICATIONS FOR USE

The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment is compatible with the following:

- Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants .
- Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants .
- Zimmer Screw-Vent 3.7mm, 4.7mm ; Zimmer Tapered Screw-Vent , 3.7mm, 4.7mm and . 6.0mm diameter implants

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Premarket Notification Section 5: Page - 5

# DEVICE DESCRIPTION

The Solidex® Customized Abutment is made of CP TI Gr4 grade unalloyed titanium for surgical implants applications (meets ASTM Standard F67/Gr 04-06) and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with:

- . Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants (510K#023113)
- . Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants (510K#071370)
- Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and � 6.0mm diameter Implants (510K#013227)

The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist.

# EQUIVALENCE TO MARKETED DEVICE

The CreoDent Solidex® Customized Abutments are substantially equivalent in intended use, material, design and performance to:

- . Nobel TDS Abutment for Nobel Biocare Replace and Abutment Screw 510K#091026
- Nobel Procera Ti Abutment and Abutment Screw 510K#091756 .
- Zimmer Patient-Specific Abutment, Internal Hex Titanium and Abutment Screw . 510K#071439

### Conclusion:

The Creodent Solidex® Customized Abutments are substantially equivalent to the identified predicate products noted in this 510K Summary.

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Premarket Notification Section 5: Page – 6

Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed:

.

| Technological<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw<br>K#113738 | Predicate Device for claimed<br>equivalence: Nobel TDS Abutment<br>for Nobel Biocare Replace and<br>Abutment Screw 510K#091026 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | -Abutment: CP Ti Gr4 unalloyed titanium<br>for surgical implants applications meets<br>ASTM F67/Gr 04-06 Standard<br>-Abutment Screw: Ti-6Al-4V Eli<br>titanium alloy meets ASTM F-136<br>Standard | -Abutment: Comparable Titanium<br>alloy<br>-Abutment Screw: Comparable<br>Titanium alloy |
| Performance<br>Characteristics | Allows the prosthesis to be cemented or<br>screw retained to the abutment. The<br>abutment screw is designed to secure the<br>abutment to the endosseous implant. | Allows the prosthesis to be cemented<br>or screw retained to the abutment. The<br>abutment screw is designed to secure<br>the abutment to the endosseous<br>implant. |
| Indications for<br>Use | The CreoDent Solidex® Customized<br>Abutment is intended for use with an<br>endosseous implant to support a prosthetic<br>device in patients who are partially or<br>completely edentulous. The device can be<br>used for single or multiple-unit restorations.<br>The prosthesis can be cemented or screw<br>retained to the abutment. An abutment screw<br>is used to secure the abutment to the<br>endosseous implant.<br><br>The CreoDent Solidex® Customized<br>Abutment is compatible with the following:<br>Nobel Replace™ TiUnite Endosseous<br>3.5mm, 4.3mm, and 5.0mm diameter<br>Implants Nobel Active™ Internal Connection<br>3.5mm and 4.3mm diameter Implants Zimmer Screw-Vent 3.7mm, 4.7mm;<br>Zimmer Tapered Screw-Vent 3.7mm,<br>4.7mm and 6.0mm diameter Implants | TDS Abutment for Nobel Biocare<br>Replace is intended for use with dental<br>implants as support for single or<br>multiple tooth prosthesis in the<br>maxilla or mandible of a partially or<br>fully edentulous patient. |
| Dimensions<br>and<br>Angulations | Abutment sizes for Nobel Replace™ TiUnite<br>Endosseous 3.5mm (NP), 4.3mm (RP), and<br>5.0mm (WP) diameter implants. | Abutment sizes for Nobel Replace ™<br>TiUnite Endosseous 3.5mm (NP), 4.3mm<br>(RP), and 5.0mm (WP) diameter implants. |
| | Angles not to exceed up to 20 degrees from | Angles not to exceed up to 20 degrees from |

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| the implant axis. | | | from the implant axis. | | | | from the implant axis. | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--|
| Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Nobel Replace™ TiUnite Endosseous implant system for which they are intended. Table #2 Legally marketed predicate device (Abutment) to which equivalence is claimed: | | | | | | Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E<br>Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for<br>the Solidex® Customized Abutment connection platform. These results demonstrated that the Solidex®<br>customized Abutment have sufficient mechanical strength for their intended clinical application and are<br>compatible with the Nobel Active™ Internal Connection implant system for which they are intended.<br>Table #3 Legally marketed predicate device (Abutment) to which equivalence is claimed: | | |
| Technological<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw<br>K#113738 | Predicate Device for claimed<br>equivalence: Nobel Procera Ti<br>Abutment and Abutment Screw<br>510K#091756 | Technological<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw<br>K#113738 | Predicate Device for claimed<br>equivalence: Zimmer Patient-<br>Specific Abutment, Internal Hex<br>Titanium and Abutment Screw<br>510K#071439 | | | |
| Material | -Abutment: CP Ti Gr4 unalloyed titanium for surgical implants<br>applications meets ASTM F67/Gr 04-06 Standard<br>-Abutment Screw: Ti-6Al-4V Eli titanium alloy meets ASTM F-136 Standard | -Abutment: Comparable Titanium alloy<br>-Abutment Screw: Comparable Titanium alloy | Material | -Abutment: CP Ti Gr4 unalloyed<br>titanium for surgical implants<br>applications meets ASTM F67/Gr<br>04-06 Standard<br>-Abutment Screw: Ti-6Al-4V Eli<br>titanium alloy meets ASTM F-136<br>Standard | -Abutment: Comparable Titanium<br>alloy<br>-Abutment Screw: Comparable<br>Titanium alloy | | | |
| Performance<br>Characteristics | Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | Allows the prosthesis to be cemented or screw retained to the abutment. The abutment screw is designed to secure the abutment to the endosseous implant. | Performance<br>Characteristics | Allows the prosthesis to be<br>cemented or screw retained to the<br>abutment. The abutment screw is<br>designed to secure the abutment to<br>the endosseous implant. | Allows the prosthesis to be cemented<br>or screw retained to the abutment. The<br>abutment screw is designed to secure<br>the abutment to the endosseous<br>implant. | | | |
| Indications for<br>Use | The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.<br><br>The CreoDent Solidex® Customized Abutment is compatible with the following:<br>Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants | The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. | Indications for Use | The CreoDent Solidex® Customized<br>Abutment is intended for use with an<br>endosseous implant to support a<br>prosthetic device in patients who are<br>partially or completely edentulous. The<br>device can be used for single or<br>multiple-unit restorations. The<br>prosthesis can be cemented or screw<br>retained to the abutment. An abutment<br>screw is used to secure the abutment<br>to the endosseous implant.<br><br>The CreoDent Solidex® Customized<br>Abutment is compatible with the<br>following:<br>• Nobel Replace™ TiUnite<br>Endosseous 3.5mm, 4.3mm,<br>and 5.0mm diameter Implants<br>• Nobel Active™ Internal<br>Connection 3.5mm and 4.3mm<br>diameter Implants<br>• Zimmer Screw-Vent 3.7mm,<br>4.7mm; Zimmer Tapered<br>Screw-Vent 3.7mm, 4.7mm | The Zimmer® Patient-Specific Abutment<br>is used as a terminal or intermediate<br>abutment for a cemented prosthesis. The<br>abutment can be used for a single or<br>multiple-unit restoration. | | | |
| Dimensions and<br>Angulations | Abutment sizes for Nobel Active™ Internal Connection 3.5mm (NP) and 4.3mm (RP) diameter implants.<br><br>Angles not to exceed up to 20 degrees | Abutment sizes for Nobel Active™ Internal Connection 3.5mm (NP) and 4.3mm (RP) diameter implants. | | | | | | |

. . . . . . . . .

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.

:

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| Angulations | Screw-Vent 3.7mm (NP), 4.7mm (RP) and 6.0mm diameter implants.<br>Angles not to exceed up to 20 degrees from the implant axis. | 3.7mm (NP), 4.7mm (RP) and 6.0mm diameter implants.<br>Angles not to exceed up to 30 degrees from the implant axis. |
|-------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
|-------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|

Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for thended clinical application and are compatible with the Zimmer Tapered Screw-Vent implant system for which they are intended.

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Table #4 Legally marketed predicate device (Implant) to which compatibility is claimed for the Solidex® Customized Abutment:

| Compatible Device | Implant Diameters | Implant Lengths |
|-------------------------|-------------------|-----------------|
| Nobel ReplaceTM TiUnite | 3.5mm | 10.0mm |
| Endosseous Implant | 3.5mm | 13.0mm |
| 510K#023113 | 3.5mm | 16.0mm |
| Nobel ReplaceTM TiUnite | 4.3mm | 10.0mm |
| Endosseous Implant | 4.3mm | 13.0mm |
| 510K#023113 | | |
| Nobel ReplaceTM TiUnite | 5.0mm | 10.0mm |
| Endosseous Implant | 5.0mm | 13.0mm |
| 510K#023113 | | |

Table #5 Legally marketed predicate device (Implant) to which compatibility for the Solidex® Customized Abutment:

| Compatible Device | Implant Diameters | Implant Lengths |
|-------------------------------------------------------------|-------------------|-----------------|
| Nobel Active™ Internal<br>Connection Implant<br>510K#071370 | 3.5mm | 10.0mm |
| Nobel Active™ Internal<br>Connection Implant<br>510K#071370 | 3.5mm | 11.5mm |
| Nobel Active™ Internal<br>Connection Implant<br>510K#071370 | 3.5mm | 13.0mm |
| Nobel Active™ Internal<br>Connection Implant<br>510K#071370 | 3.5mm | 15.0mm |
| Nobel Active™ Internal<br>Connection Implant<br>510K#071370 | 4.3mm | 10.0mm |
| Nobel Active™ Internal<br>Connection Implant<br>510K#071370 | 4.3mm | 11.5mm |
| Nobel Active™ Internal<br>Connection Implant<br>510K#071370 | 4.3mm | 13.0mm |
| Nobel Active™ Internal<br>Connection Implant<br>510K#071370 | 4.3mm | 15.0mm |

Table #6 Legally marketed predicate device (Implant) to which compatibility for the Solidex® Customized Abutment:

| Compatible Device | Implant Diameters | Implant Lengths |
|------------------------------------------------------------------|-------------------|-----------------|
| Zimmer Screw-Vent , Tapered<br>Screw-Vent Implant<br>510K#013227 | 3.7mm | 8.0mm – 16.0mm |
| Zimmer Screw-Vent , Tapered<br>Screw-Vent Implant<br>510K#013227 | 4.7mm | 8.0mm – 16.0mm |
| Zimmer Tapered Screw-Vent<br>Implant 510K#013227 | 6.0mm | 8.0mm – 16.0mm |

.

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Image /page/7/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

SEP 1 7 2013

CreoDental Prosthetics, Limited Mr. Calvin Shim Managing Director 29 West 30th Street, 11th floor NEW YORK NY 10001

Re: K113738

Trade/Device Name: CreoDent Solidex® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: September 9, 2013 Received: September 11, 2013

Dear Mr. Shim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Shim

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KII3738

### Premarket Notification Section 4: Page - 3

#### Indications for Use

510(k) Number (if known) K113738

Device Name: CreoDent Solidex® Customized Abutment

Indication for Use:

The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.

The CreoDent Solidex® Customized Abutment is compatible with the following:

- Nobel Replace™ TiUnite Endosseous 3.5mm, 4.3mm, and 5.0mm diameter Implants .
- Nobel Active™ Internal Connection 3.5mm and 4.3mm diameter Implants .
- Zimmer Screw-Vent 3.7mm, 4.7mm; Zimmer Tapered Screw-Vent 3.7mm, 4.7mm and 6.0mm diameter Implants

Prescription Use X · (Part 21 CFR 801 Subpart D)

AND/OR Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Andrew I. Steen -S f 2013.09.17 14:33:09 -0

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: