RADIANCE

K080749 · American Orthodontics · NJM · Aug 4, 2008 · Dental

Device Facts

• Record ID: K080749
• Device Name: RADIANCE
• Applicant: American Orthodontics
• Product Code: NJM · Dental
• Decision Date: Aug 4, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Radiance is an orthodontic bracket. Orthodontic brackets are prescribed for patients with teeth that are not normally positioned in the mouth. An orthodontic bracket is a device consisting of a base, an arch wire slot and four tie wings. The bracket bases are attached to a patient's teeth with adhesive. A metal arch wire is placed in the arch wire slot of a set of brackets (typically ten brackets on each of the upper and lower arches) and the wire is held in place in each bracket slot with an elastic o-ring placed under the tie wings and over the arch wire. Orthodontic treatment is used to correct dental deficiencies and to improve the appearance of the patient. The brackets, arch wire and elastic o-rings form a force system that is designed to gradually move teeth into a normal alignment. Radiance brackets can enhance the patient's appearance during treatment because the bracket is highly transparent. These brackets are less visible than metal brackets and are preferred by many patients – especially adults.

Device Story

Radiance is a transparent orthodontic bracket system; consists of base, arch wire slot, and four tie wings. Attached to teeth via adhesive; metal arch wire inserted into slot; secured by elastic o-rings. System creates force to gradually move teeth into alignment. Used in clinical orthodontic settings by dental professionals. Highly transparent material provides aesthetic benefit over traditional metal brackets, particularly for adult patients.

Clinical Evidence

No clinical data provided; device is a standard orthodontic bracket relying on established mechanical principles for tooth movement.

Technological Characteristics

Orthodontic bracket; transparent plastic construction; includes base, arch wire slot, and tie wings. Mechanical force system utilizing arch wires and elastic o-rings. No electronic or software components.

Indications for Use

Indicated for patients requiring orthodontic treatment to correct malpositioned teeth and dental deficiencies.

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 4 2008

Mr. Jerome H. Schomberg Vice President-Engineering American Orthodontics Corporation 1714 Cambridge Avenue Sheboygan, Wisconsin 53081

Re: K080749

Trade/Device Name: Radiance Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: July 8, 2008 Received: July 14, 2008

Dear Mr. Schomberg:

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. Schomberg

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

TKamnels-Lund, MD for JCC

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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# 680149

## RADIANCE: 510(k) NUMBER K080749

## ADDENDUM TO THE SUBMITTAL OF MARCH 7, 2008

### STATEMENT OF INDICATIONS FOR USE

Radiance is an orthodontic bracket. Orthodontic brackets are prescribed for patients with teeth that are not normally positioned in the mouth. An orthodontic bracket is a device consisting of a base, an arch wire slot and four tie wings. The bracket bases are attached to a patient's teeth with adhesive. A metal arch wire is placed in the arch wire slot of a set of brackets (typically ten brackets on each of the upper and lower arches) and the wire is held in place in each bracket slot with an elastic o-ring placed under the tie wings and over the arch wire.

Orthodontic treatment is used to correct dental deficiencies and to improve the appearance of the patient. The brackets, arch wire and elastic o-rings form a force system that is designed to gradually move teeth into a normal alignment. Radiance brackets can enhance the patient's appearance during treatment because the bracket is highly transparent. These brackets are less visible than metal brackets and are preferred by many patients – especially adults.

Suna Runney

(Division Sign-Off Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K080749