PREFORMANCE TEMPORARY CYLINDER

K060291 · Implant Innovations, Inc. · NHA · Feb 27, 2006 · Dental

Device Facts

• Record ID: K060291
• Device Name: PREFORMANCE TEMPORARY CYLINDER
• Applicant: Implant Innovations, Inc.
• Product Code: NHA · Dental
• Decision Date: Feb 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PreFormance 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 Temporary Cylinders are dental implant accessories used to support provisional prostheses during healing. Fabricated from PEEK, these cylinders feature a material retention mechanism on the body to secure the restoration. Used in clinical dental settings by practitioners, the device supports single or multiple unit prostheses via screw or cement retention. The cylinders provide temporary structural support for up to 180 days during the healing phase of endosseous dental implants. They are restricted to non-occlusal loading to prevent premature stress on the healing implant site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: PEEK. Form factor: Cylinder with material retention feature. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for partially or fully edentulous patients requiring support for single or multiple unit provisional dental 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)

Submission Summary (Full Text)

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K06029/

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

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## -EB % 7 2006 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 | January 20, 2006 |
| Device Name | PreFormance Temporary Cylinders |
| Classification Name | Endosseous Dental Implant |
| 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 PreFormance Temporary Cylinders will be made of<br>the same material (PEEK) as the PreFormance Posts. The<br>temporary cylinders have a material retention feature |
| located on the cylinder body area, whereas the posts do<br>not have this feature on the post body. | |
| Indications for Use | The PreFormance Temporary Cylinders are intended for<br>use as an accessory to endosseous dental implants to<br>support a prosthetic device in a partially or fully<br>edentulous patient. They are intended for use to support<br>single and multiple unit prostheses in the mandible or<br>maxilla for up to 180 days during endosseous and<br>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 Temporary Cylinders are made of the<br>same material and contain features and functions which<br>are similar to the currently available PreFormance Posts. |
| Conclusion | The PreFormance 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 features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2006

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

Re: K060291

Trade/Device Name: Performance Temporary Cylinder Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: January 20, 2006 Received: February 6, 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 mendments, 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 (1 will), it neg of 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. Jim 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 requirence as betrenir 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), r you dontact 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 Internation 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,

Susan Runre

2 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. Inforant Innovations, the

K060291

Page 1 of 1

510(k) Number (if known): _

Device Name: PreFormance Temporary Cylinders

Indications for Use:

The PreFormance 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X
(Per 21 CFR 801.109)

OR

Over the Counter Use:

Kein Haley for MSR

logy, General Hospital,
Control Dental Devices

K 060291