TEMPBOND CLEAR WITH TRICLOSAN

K053565 · Sybron Dental Specialties, Inc. · EMA · Feb 3, 2006 · Dental

Device Facts

• Record ID: K053565
• Device Name: TEMPBOND CLEAR WITH TRICLOSAN
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EMA · Dental
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

The intended use of TempBond Clear with Triclosan is for the temporary cementation of temporary restorations such as crowns, bridges, inlays, onlays and splints.

Device Story

TempBond Clear with Triclosan is a dual-cured, eugenol-free, resin-based temporary dental cement containing triclosan. Packaged in a dual-barrel syringe to eliminate manual mixing; provides flowable consistency for seating restorations. Used by dental professionals in clinical settings to secure temporary crowns, bridges, inlays, onlays, and splints. Material is flexible and transparent when cured; strong enough for mastication stresses while allowing for easy removal of restorations. Benefits include simplified application and antimicrobial properties from triclosan.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cured, eugenol-free, resin-based cement. Supplied in a dual-barrel syringe. Contains triclosan. Transparent and flexible when cured.

Indications for Use

Indicated for temporary cementation of temporary dental restorations including crowns, bridges, inlays, onlays, and splints. For prescription use only.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• TempBond Clear (Kerr Corporation)

Submission Summary (Full Text)

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K053565

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters "SDS" in a stylized font, with a swooping line above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are printed in a simple, sans-serif font. The logo is black and white.

FEB 3 2006

# Section III - 510(k) Summary of Safety and Effectiveness

## Submitter:

Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

December 2005 Date Summary Prepared:

#### Device Name:

- Trade Name -- TempBond Clear with Triclosan .
- Common Name Temporary Dental Cement .
- Classification Name Dental Cement other than zinc oxide-eugenol, per 21 CFR . 8 872.3275 (b)

### Devices for Which Substantial Equivalence is Claimed:

- Kerr Corporation, TempBond Clear .
#### Device Description:

TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, resin-based cement with triclosan. This base/catalyst cement is flexible and transparent when cured. The device will be packaged in a dual-barrel syringe to eliminate hand mixing. It has excellent flow to permit the restoration to be easily and completely seated. It is strong enough to withstand the stresses of mastication, yet permits easy removal of the restoration when it is desired. TempBond Clear with Triclosan contains triclosan.

#### Intended Use of the Device:

The intended use of TempBond Clear with Triclosan is for the temporary cementation of temporary restorations such as crowns, bridges, inlays, onlays and splints.

#### Substantial Equivalence:

TempBond Clear with Triclosan is substantially equivalent to other legally marketed devices in the United States. This temporary dental cement which will be manufactured by Kerr Corporation functions in a manner similar to and is intended for the same use as the product currently marketed by Kerr.

8

Sybron Dental Specialties 100 Bayview Circle, Suite 6000 Newport Beach, CA 92660-8915 800.537.7824 949.55.8700 www.sybrondental.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services.

FEB 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, Califorina 92660

Re: K053565

Trade/Device Name: TempBond Clear with Triclosan Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: December 21, 2005 Received: December 22, 2005

Dear Ms. Boswell:

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. Colleen Boswell

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" (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.

Chau S. Lin, PhD

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): |< 05 3565

Device Name: TempBond Clear with Triclosan

Indications For Use:

TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, transparent, resin-based cernent with triclosan designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays, onlays and splints.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Susan Runne

(Division Sup-Off) (Division Ship. On)
Division of Anal Charletogy, Ocheral Hospital, Division Centrel, Dantal Devices

510(k) Number: K05 3565