PREFORMANCE POSTS AND TEMPORARY CYLINDERS

K061969 · Implant Innovations, Inc. · NHA · Jul 21, 2006 · Dental

Device Facts

• Record ID: K061969
• Device Name: PREFORMANCE POSTS AND TEMPORARY CYLINDERS
• Applicant: Implant Innovations, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 21, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The PreFormance Abutment Posts and Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the abutment.

Device Story

PreFormance Abutment Posts and Temporary Cylinders are dental accessories used to support provisional prostheses during healing. Fabricated from PEEK; available in straight or 15° pre-angled configurations. Cylinders feature hexed (single unit) or non-hexed (multi-unit) connections. Designed to interface with 3i external connection implants. Used by dental clinicians in a clinical setting to support screw or cement-retained restorations. Provides temporary prosthetic support during the 180-day healing period; facilitates gingival healing; enables non-occlusal loading of provisional restorations.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: PEEK. Configuration: Straight or 15° pre-angled posts; straight cylinders. Connection: Hexed (single unit) or non-hexed (multi-unit) for external connection implants. Non-powered, mechanical dental abutment.

Indications for Use

Indicated for partially or fully edentulous patients requiring support for single or multiple unit provisional prostheses in the mandible or maxilla during endosseous and gingival healing (up to 180 days). For non-occlusal loading only.

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

• PreFormance™ Posts (K053170)
• PreFormance™ Temporary Cylinders (K060291)

Submission Summary (Full Text)

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K061969

## 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93

| Submitter | Implant Innovations, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Jim Banic<br>Regulatory Affairs Specialist<br>Implant Innovations, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410<br>Tel. [phone]<br>Fax. [phone]<br>Email: [e-mail] |
| Date Prepared | July 3, 2006 |
| Device Name | PreFormance™ Abutment Posts and Temporary Cylinders |
| Classification Name | Endosseous Dental Implant Abutment |
| Device<br>Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3630 |
| Predicate<br>Devices | PreFormance™ Posts -> K053170<br>PreFormance™ Temporary Cylinders -> K060291 |
| Performance | Performance standards have not been established by the<br>FDA under Section 514 of the Federal Food, Drug and<br>Cosmetic Act. |
| Device Description | The PreFormance™ Abutment Posts and Temporary Cylinders will be made of the same material (PEEK) as the predicate PreFormance™ Posts and Temporary Cylinders.<br>The posts will be available in both straight and 15° pre-angled configurations while the cylinders will be straight.<br>The cylinders will have either a hexed or non-hexed connection. The hexed connection is for single unit prostheses while the non-hexed is for multi use. The posts and cylinders will connect to 3i's externally connected implants. |
| Indications for Use | The PreFormance Abutment Posts and Temporary<br>Cylinders are intended for use as an accessory to<br>endosseous dental implants to support a prosthetic device<br>in a partially or fully edentulous patient. They are intended<br>for use to support single and multiple unit prostheses in the<br>mandible or maxilla for up to 180 days during endosseous<br>and gingival healing, and are for non occlusal loading of<br>single and multiple unit provisional restorations. The<br>prostheses can be screw or cement retained to the<br>abutment. |
| Technological<br>Characteristics | The PreFormance™ Abutment Posts and Temporary<br>Cylinders have the same technological characteristics as<br>the currently available PreFormance™ Abutment Posts and<br>Temporary Cylinders. The modification is solely in the<br>connection to the implant. The predicate device mates with<br>the internal connection implant design while the modified<br>device mates with the external hexed implant design. |
| Conclusion | The PreFormance™ Abutment Posts and Temporary<br>Cylinders are substantially equivalent to the legally<br>marketed PreFormance™ Abutment Posts and Temporary<br>Cylinders. |

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Kolo 1969

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings, and a caduceus symbol is visible in the lower part of the eagle. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 1 2006

Mr. Jim Banic Regulatory Affairs Specialist Implant Innovations. Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K061969

Trade/Device Name: PreFormance Posts Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 3, 2006 Received: July 12, 2006

Dear Mr. Banie:

We have reviewed vour 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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. Banic

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Pari 807.97). 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-fire number [phone] or [phone] or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification PreFormance™ Abutment Posts and Temporary Cylinders

## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: PreFormance Posts

Indications for Use:

The PreFormance Abutment Posts and Temporary Cylinders are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support single and multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of single and multiple unit provisional restorations. The prostheses can be screw or cement retained to the aburment,

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Karl-Betz DVS (e.V.) Susann Kamke*
1945

of Anesihestology, General Hospital n Control. Dental Device

ictor Kobi 1969