(27 days)
Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. The devices are for Orthodontic Use Only, on the order of an Orthodontist.
Rave Composite Bracket
This document is a 510(k) clearance letter from the FDA for a medical device (Rave Composite Bracket) and does not contain the specific information requested about acceptance criteria and study details.
The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It outlines regulatory requirements but does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Results of a standalone algorithm-only performance study.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is primarily regulatory approval, not a scientific study report.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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): _
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
Page 8-1
§ 872.5470 Orthodontic plastic bracket.
(a)
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.(b)
Classification. Class II.