PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM

K061252 · Primus Consulting · DYH · Feb 12, 2007 · Dental

Device Facts

• Record ID: K061252
• Device Name: PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
• Applicant: Primus Consulting
• Product Code: DYH · Dental
• Decision Date: Feb 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pre-Cemented Orthodontic Bracket System is indicated for use in bonding orthodontic appliances for orthodontic treatment.

Device Story

System consists of pre-cemented orthodontic brackets and optional bonding tray; used for bonding orthodontic appliances to teeth during orthodontic treatment. Components are legally marketed medical devices. System simplifies bracket placement process for clinicians. No changes in formulation from predicate devices.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

System comprises pre-cemented orthodontic brackets and optional bonding tray. Components are legally marketed devices. No changes in formulation from predicate devices.

Indications for Use

Indicated for use in bonding orthodontic appliances for orthodontic treatment in patients requiring orthodontic care.

Regulatory Classification

Identification

A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

Predicate Devices

• APC™ Plus Adhesive (K020394)

Submission Summary (Full Text)

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FEB 1 2 2007

## 510(k) SUMMARY

| Owner/Contact Information: | | |
|-------------------------------------------------------------------------------------------|--|--------------|
| Dr. Carolyn Primus<br>Primus Consulting<br>7046 Owl's Nest Terrace<br>Bradenton, FL 34203 | | 941-753-9737 |

| Date Summary Prepared: | May 1, 2006 |
|------------------------|-------------|
|------------------------|-------------|

Pre-Cemented Orthodontic Bracket System Draft Trade Name:

FDA Classification Name and Number: Bracket adhesive resin and tooth conditioner, 872.3750 Resin impression tray material, 872.3670

APC™ Plus Adhesive K020394 Legally Marketed Predicate Devices

Description of the Device: The Pre-Cemented Orthodontic Bracket System consists of precemented orthodontic brackets and an optional bonding tray. The orthodontic brackets and component used in the application are currently marketed medical devices.

Intended use: The Pre-Cemented Orthodontic Bracket System is indicated for use in bonding orthodontic appliances for orthodontic treatment.

Technological Characteristics: All of the components found in the Pre-Cemented Orthodontic Bracket System are legally marketed devices or are found in legally marketed devices. As there are no changes in formulation from the predicate devices, we believe that additional biocompatibility testing is not required.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The overall design is simple and professional, conveying a sense of authority and trustworthiness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Carolyn M. Primus Official Correspondent Primus Consulting 7046 Owl's Nest Terrace Bradenton, Florida 34203

FEB 1 % 2007

Re: K061252

Trade/Device Name: Pre-Cemented Orthodontic Bracket System Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: January 4, 2007 Received: January 22, 2007

Dear Dr. Primus:

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 - Dr. Primus

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,

Clare

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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## Indications for Use

510(K) Number (if known): K061252

Device Name: Pre-Cemented Orthodontic Bracket System

Indications for Use:

Indicated for use in bonding orthodontic appliances for orthodontic treatment

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Clare

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K061252