TEMPFX ESTHETIC PROVISIONAL SYSTEM

K061264 · Dentsply International, Inc. · EBG · May 23, 2006 · Dental

Device Facts

• Record ID: K061264
• Device Name: TEMPFX ESTHETIC PROVISIONAL SYSTEM
• Applicant: Dentsply International, Inc.
• Product Code: EBG · Dental
• Decision Date: May 23, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional dental restorations.

Device Story

TempFX Esthetic Provisional System consists of visible light-cured resin-based composites and accessories. Used by dental professionals to fabricate provisional restorations for patients awaiting final prosthodontic treatment. The system utilizes light-curing technology to harden the resin material into the desired provisional shape. Benefits include providing temporary protection and esthetics for the patient during the interim period before final restoration placement.

Clinical Evidence

Bench testing only. Biocompatibility testing performed for cytotoxicity, mutagenicity, dermal sensitization, and irritation.

Technological Characteristics

Visible light-cured resin-based composite system. Components consist of materials previously used in legally marketed dental devices. Biocompatibility verified per standard dental safety requirements.

Indications for Use

Indicated for fabrication of provisional dental restorations in patients awaiting final prosthodontic restoration.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Predicate Devices

• New Triad VLC Crown & Bridge Provisional Material (K904251)

Submission Summary (Full Text)

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K661264

# 510(k) SUMMARY

## MAY 2 3 2006

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|---------------------------------------------------------------|
| DATE PREPARED: | May 1, 2006 |
| TRADE OR PROPRIETARY NAME: | TEMPFX ESTHETIC PROVISIONAL SYSTEM |
| CLASSIFICATION NAME: | Temporary crown and bridge resin, 872.3770 |
| PREDICATE DEVICES: | New Triad VLC Crown & Bridge Provisional<br>Material, K904251 |

## DEVICE DESCRIPTION:

The TEMPFX ESTHETIC PROVISIONAL SYSTEM includes visible light cured resin based composites and accessories used to create provisional restorations for patients awaiting final prosthodontic restoration.

INTENDED USE:

TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional dental restorations.

### TECHNOLOGICAL CHARACTERISTICS:

All of the components found in TEMPFX ESTHETIC PROVISIONAL SYSTEM have been used in legally marketed devices and/or were found safe for dental use. TEMPFX ESTHETIC PROVISIONAL SYSTEM has been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, dermal sensitization and irritation.

We believe that the prior use of the components of TEMPFX ESTHETIC PROVISIONAL SYSTEM in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the TEMPFX ESTHETIC PROVISIONAL SYSTEM for the indicated use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping birds in flight, rendered in black.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2006

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K061264

Trade/Device Name: TempFX Esthetic Provisional System Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: May 01, 2006 Received: May 05, 2006

## Dear Ms. Lewis:

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 - Ms. Helen Lewis

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 (OS) 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" (21 CFR 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.

Chiu S. Lin, PhD

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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## INDICATIONS FOR USE

510(K) Number (if known):

TEMPFX ESTHETIC PROVISIONAL SYSTEM Device Name:

11061264

Indications for Use:

TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional dental restorations.

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)

Susan Runner

... of Anachesiology, General Hospits),

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