PREFORMANCE POSTS

K053170 · Implant Innovations, Inc. · NHA · Feb 1, 2006 · Dental

Device Facts

• Record ID: K053170
• Device Name: PREFORMANCE POSTS
• Applicant: Implant Innovations, Inc.
• Product Code: NHA · Dental
• Decision Date: Feb 1, 2006
• Decision: SESE
• Submission Type: Traditional
• 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 Posts are dental abutment accessories used to support provisional prostheses during healing. Device consists of PEEK material with a titanium insert; available in straight and 15° pre-angled configurations with 4mm or 6mm collar heights and 7mm post height. Used by dentists in clinical settings to support screw or cement-retained single/multiple unit restorations. Provides temporary support for up to 180 days during the healing phase of endosseous dental implants. Benefits include facilitating provisional restoration during the healing period.

Clinical Evidence

Bench testing only. Laboratory testing conducted to determine device functionality and conformance to design input requirements and FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis performed in accordance with ISO 14971.

Technological Characteristics

Materials: PEEK with titanium insert. Configurations: Straight and 15° pre-angled. Dimensions: 4mm/6mm collar heights, 7mm post height. Function: Accessory to endosseous dental implants for provisional prosthetic support. Connectivity: None. Sterilization: Not specified.

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). Intended for non-occlusal loading.

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

• GingiHue Abutments (K871954)
• GingiHue Pre-Angled Abutments (K932123)

Submission Summary (Full Text)

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K053170

Implant Innovations, Inc.

510(k) Premarket Notification - PreFormance™ Post

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## 510(k) Summary

#### 2006 FER 1

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 | November 11, 2005 |
| Device Name | PreFormance Post |
| Classification Name | Dental Abutments |
| Device Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3630 |
| Predicate Devices | GingiHue Abutments -> K871954<br>GingiHue Pre-Angled Abutments -> K932123 |
| 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 Post will be shaped similar to the<br>currently marketed GingiHue Post. However, the<br>PreFormance Post will be made of PEEK with a titanium<br>insert. The posts will be available in straight and 15° pre-<br>angled configurations. The collar height on the<br>PreFormance Post will be 4mm and 6mm and the post |

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K053170

## Implant Innovations, Inc. 510(k) Premarket Notification - PreFormance™ Post

Technological Characteristics height will be 7mm.

· The PreFormance Abutment Posts are intended for use as Indications for Use 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. The prostheses can be screw or cement retained to the abutment.

> Substantial equivalence of the PreFormance Posts is based on:

1. Design features which are similar to the currently available GingiHue Posts. The PreFormance Posts are made of PEEK with a titanium insert

2. Performance testing. The proposed and currently marketed devices are identical in terms of size, biocompatibility, performance characteristics and basic design.

Laboratory testing was conducted to determine device Performance Testing functionality and conformance to design input requirements, as well as FDA's Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk Analysis was conducted in accordance with ISO 14971.

### The PreFormance Posts are equivalent to the GingiHue Conclusion Posts which provide similar functionality.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is a stylized image of an eagle with three heads, which is a common symbol used by the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2006

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

Re: K053170 Trade/Device Name: PreFormance Posts Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 13, 2006 Received: January 17, 2006

Dear Mr. Banic:

This letter corrects our substantially equivalent letter of February 1, 2006.

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 (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 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. 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 continue 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 Part 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-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

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# Indications for Use

510(k) Number (if known): K053170

Device Name: PerFormance 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 abutment.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert S. Betz, DDS for Dr. Susan Runner

cion Sign-Ctr)
sion of Anesthesiology, General Hospital,
Cction Control, Dental Devices
Number: K053170