DAMON FT

K032408 · Sybron Dental Specialties, Inc. · DYW · Oct 15, 2003 · Dental

Device Facts

• Record ID: K032408
• Device Name: DAMON FT
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: DYW · Dental
• Decision Date: Oct 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Damon FT is a plastic orthodontic bracket that is designed for the movement of teeth during orthodontic treatment.

Device Story

Damon FT is a polycarbonate orthodontic bracket system for maxillary and mandibular teeth (second bicuspid to second bicuspid). Device features aesthetic and self-ligating qualities; includes metal archwire slot for performance; rhomboid design for placement; increased corner radius for patient comfort. Used by orthodontists in clinical settings to facilitate tooth movement during orthodontic treatment. Functions similarly to existing orthodontic brackets without altering established treatment mechanics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polycarbonate orthodontic bracket; self-ligating design; metal archwire slot; rhomboid shape; intended for maxillary and mandibular teeth.

Indications for Use

Indicated for patients requiring orthodontic treatment for the movement of teeth.

Regulatory Classification

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Predicate Devices

• Ormco Corporation, Spirit MB

Reference Devices

• Damon 2 bracket

Submission Summary (Full Text)

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K032408

OCT 1 5 2003

S< ction III - 510(k) Summary of Safety and Effectiveness

## Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

August 2003 Date Summary Prepared:

### I Device Name:

- Trade Name Damon FT (
- 1 : Common Name - Plastic Orthodontic Bracket
- Classification Name Bracket, Plastic, Orthodontic, per 21 CFR § 872.5470 :

### Devices for Which Substantial Equivalence is Claimed:

- D Orinco Corporation, Spirit MB
### Device Description:

The device is a polycarbonate orthodontic bracket which will encompass maxillary and mandibular brackets from second bicuspid to second bicuspid. The Damon FT appliance has both aesthetic and self-ligating qualities. The Damon FT bracket is designed to 1) increase patient comfort, with its increased corner radius. 2) enhance bracket placement, with its rhomboid design, and 3) improve overall bracket performance without changing treatment mechanics, with its metal archwire slot, rotation control similar to Damon 2 bracket, and compatibility with the Damon 2 bracket.

### Intended Use of the Device:

The intended use of Damon FT is as a plastic orthodontic bracket that is designed for the movement of teeth during orthodontic treatment.

### Substantial Equivalence:

Damon FT is substantially equivalent to other legally marketed devices in the United States. Damon FT functions in a manner similar to and is intended for the same use as the Spirit MB bracket marketed by Ormco Corporation.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 1 5 2003

Mr. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K032408

Trade/Device Name: Damon FT Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: August 1, 2003 Received: August 4, 2003

Dear Mr. 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 - Mr. 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 (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" (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 vours.

Clufs

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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Se :tion I - Indications for Use

Ver/ 3 - 4 '24/96 Applicant: Ormco Corporation 032408 510(k) Number (if known): __ Device Name. Damon FT Indicat ons For Use: Damor FT is a polycarbonate bracket system intended to aid in the movement of patient's teeth during orthodontic treatment. Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:_ 1 12 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)