ORTHODONTIC POLYMER COMPOSITE BRACKET

K053055 · Gestenco International AB · DYW · Dec 22, 2005 · Dental

Device Facts

• Record ID: K053055
• Device Name: ORTHODONTIC POLYMER COMPOSITE BRACKET
• Applicant: Gestenco International AB
• Product Code: DYW · Dental
• Decision Date: Dec 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Orthodontic Polymer Composite Bracket is intended to be bonded on teeth to aid in the movement of patient's teeth during orthodontic treatment.

Device Story

Orthodontic Polymer Composite Bracket; bonded to teeth by orthodontists to facilitate tooth movement during orthodontic treatment. Device functions as mechanical attachment point for orthodontic wires/elastics. Used in clinical dental settings. Benefits patient by enabling controlled orthodontic correction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polymer composite orthodontic bracket; intended for bonding to tooth enamel. Class II device (872.5470).

Indications for Use

Indicated for patients undergoing orthodontic treatment requiring tooth movement via bonded brackets.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

DEC 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Göran Steen President Gestenco International AB Fridkullagatan 14 Göteborg, Sweden SE 400 22

Re: K053055

Trade/Device Name: Orthodontic Polymer Composite Bracket Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: November 21, 2005 Received: November 23, 2005

Dear Mr. Steen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because rised the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in muncations for use stated in the 222, 1976, the enactment date of the Medical Device mensiale commerce prior to that have been reclassified in accordance with the provisions of Amendinens, or to active and Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 000, Drug, and Ocenimay, therefore, market the device, subject to the general approvin application (the Act. The general controls provisions of the Act include controls providents of an 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 If your device is classified (boo as additional controls. Existing major regulations affecting (FMA), it may of subject to bach adata f Federal Regulations, Title 21, Parts 800 to 898. In your device ear be found the announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Steen

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,

Janette Y. Michaud, DMD.

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

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## Indications for Use

## 510(k) Number (if known): K053055

Device Name: Orthodontic Polymer Composite Bracket

## Indications for Use:

Orthodontic Polymer Composite Bracket is intended to be bonded on teeth to aid in the movement of patient's teeth during orthodontic treatment.

Prescription Use X (21 CFR Part 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rusoes

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