RAVE COMPOSITE BRACKET

K052714 · FDA Agents · DYW · Oct 26, 2005 · Dental

Device Facts

• Record ID: K052714
• Device Name: RAVE COMPOSITE BRACKET
• Applicant: FDA Agents
• Product Code: DYW · Dental
• Decision Date: Oct 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. The devices are for Orthodontic Use Only, on the order of an Orthodontist.

Device Story

Rave Composite Bracket is an orthodontic appliance used for tooth movement. Device consists of composite material brackets bonded to teeth to facilitate orthodontic treatment. Used by orthodontists in clinical settings to apply corrective forces to natural teeth. Excludes use on mandibular bicuspid teeth. Device functions as a mechanical attachment point for orthodontic wires/elastics to guide tooth alignment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Orthodontic plastic bracket; composite material construction; intended for bonding to natural teeth; Class II device (21 CFR 872.5470).

Indications for Use

Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. For use by orthodontists.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 2005

Mr. Stephan Klamic Quality and Regulatory Affairs Manager Ortho Technology Incorporated 17401 Commerce Park Boulevard Tampa, Florida 33647

Re: K052714

Trade/Device Name: Rave Composite Bracket Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: September 27, 2005 Received: September 29, 2005

Dear Mr. Klamic:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your booken on of the device is substantially equivalent (for the indications for referenced above and nave acterially marketed predicate devices marketed in interstate commerce use stated in the energant from the Medical Device Amendments, or to devices that provision with 20, 1770, the chactions as the Federal Food, Drug, and Cosmetic liave been recidissified in accorpoval of a premarket approval application (PMA). You may, Act (Act) that ao not require approvato the general controls provisions of the Act. The general thereone, mance the de rios, babyer wents for annual registration, listing of devices, good controls provisions of willibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to suel additions, 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. Stephan Klamic

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dr i boualite of a wouldevice complies with other requirements of the Act or that FDA has made a decemination and regulations and agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); an the Act 3 requiremones, moracturing practice requirements as set forth in the quality labeling (21 CFR Part 801), good need and if applicable, the electronic product radiation Systems (QB) rogar (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) I ms icher will anow you to oegin maing of substantial equivalence of your device to a legally prematication. - The PDF interior 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 ir you desire specific acres at [phone]. Also, please note the regulation entitled, Colliact inc Office of Comphanes an (21 CFR Part 807.97). You may obtain other INnsolanding by reference to psystems in the Act from the Division of Small general intornation of your corporations in 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

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): _

K052714

Device Name: Rave Composite Brackets

## Indications for Use:

Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

The devices are for Orthodontic Use Only, on the order of an Orthodontist.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ AND/OR (21 CFR 801 Subpart C)

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

Susan Runser

f Anesthesiology, General Hospital, on Control, Dental Devices

Number: K052014

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