PROVIDE TEMPORARY CYLINDER

K061177 · Implant Innovations, Inc. · NHA · May 16, 2006 · Dental

Device Facts

• Record ID: K061177
• Device Name: PROVIDE TEMPORARY CYLINDER
• Applicant: Implant Innovations, Inc.
• Product Code: NHA · Dental
• Decision Date: May 16, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Provide 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 cement retained to the abutment.

Device Story

Provide Temporary Cylinders function as dental implant accessories; cemented onto abutments to support acrylic resin provisional restorations. Used in mandible or maxilla for partially or fully edentulous patients; supports single or multi-unit prostheses. Operates via non-occlusal loading during healing phase (up to 180 days). Used by dental clinicians in clinical settings. Benefits patient by providing temporary prosthetic support during osseointegration and gingival healing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: PEEK. Form factor: Cylindrical, 6.5mm height, 4.8mm and 6.5mm platform diameters. Function: Cement-retained provisional support. Single-use (single-unit) or multi-use (splinted multi-unit).

Indications for Use

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

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)

Submission Summary (Full Text)

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K061177

### Summary of Safety and Effectiveness

MAY 16 2006

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 | 25 April 2006 |
| Device Name | Provide Temporary Cylinders |
| Classification Name | Endosseous Dental Implant Abutment |
| Device Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3630 |
| Predicate Devices | PreFormance Posts -> K053170 |
| 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 Provide Temporary Cylinders will be made of the<br>same material (PEEK) as the PreFormance Posts. The<br>cylinder is cemented onto an abutment. An acrylic resin<br>provisional restoration can be built onto the cylinder. The<br>height of these cylinders will be 6.5mm and the platform<br>diameters are 4.8 and 6.5mm. Furthermore, they will be<br>used as single use to support a single-unit restoration and<br>multi use where two or more cylinders are splinted together<br>to support a provisional multi-unit restoration |
| Indications for Use | The Provide Temporary Cylinders are intended for use as<br>an accessory to endosseous dental implants to support a<br>prosthetic device in a partially or fully edentulous patient.<br>They are intended for use to support single and multiple<br>unit prostheses in the mandible or maxilla for up to 180<br>days during endosseous and gingival healing, and are for<br>non occlusal loading of single and multiple unit provisional<br>restorations. The prostheses can be cement retained to the<br>abutment. |
| Technological<br>Characteristics | The Provide Temporary Cylinders are made of the same<br>material and contain features and functions which are<br>similar to the currently available PreFormance Posts. |
| Conclusion | The Provide Temporary Cylinders are substantially<br>equivalent to the legally marketed PreFormance Posts. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2005

Mr. Jim Banic Regulatory Affairs Specialist 3i Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K061177

Trade/Device Name: Provide Temporary Cylinders Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 25, 2006 Received: April 27, 2006

Dear Mr. Banic:

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.

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 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 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 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/industry/support/index.html.

Sincerely yours,

Snytte Y. Mickue Omd.

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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Implant Innovations, Inc. Internal Innovations, Inc.
Special 510(k) Premarket Notification – Provide™ Temporary Cylinders: Device Modification

Page 1 of 1

# 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Provide Temporary Cylinders

#### Indications for Use:

The Provide 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 cement retained to the abutment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use:** ✓
(Per 21 CFR 801.109)

OR

Over the Counter Use:

Suren Runner

of Arasthesiology, General Hospital,
...n Control, Dental Devices
Numbar: Ko61177