CLARITY MODIFIED CERAMIC BRACKETS

K062305 · 3M Unitek · NJM · Oct 18, 2006 · Dental

Device Facts

• Record ID: K062305
• Device Name: CLARITY MODIFIED CERAMIC BRACKETS
• Applicant: 3M Unitek
• Product Code: NJM · Dental
• Decision Date: Oct 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Clarity Modified Ceramic Bracket is intended for use in orthodontic treatment.

Device Story

Clarity Modified Ceramic Brackets are orthodontic appliances used for tooth alignment. Brackets are bonded to teeth by orthodontists to facilitate movement via archwires. Device serves as a mechanical interface between archwire and tooth surface; provides aesthetic alternative to metal brackets. Used in clinical orthodontic settings; applied by trained dental professionals. Benefits include correction of malocclusions and improved dental alignment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ceramic material construction; orthodontic bracket form factor; passive mechanical device; non-powered; non-sterile.

Indications for Use

Indicated for patients requiring orthodontic treatment to correct malocclusions.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 8 2006

Ms. L. Marlyn Scheff Regulatory Affairs Manager 3M Unitek Corporation 2724 South Peck Road Monrovia, California 91016

Re: K062305

Trade/Device Name: ClarityTM Modified Ceramic Brackets Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: August 4, 2006 Received: August 8, 2006

Dear Ms. Scheff:

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 - Ms. Scheff

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,

Chih-Lin, Ph.D.

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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K062305

## Indications for Use

510(k) Number (if known):

Device Name:

Clarity™ Modified Ceramic Brackets

Indications For Use:

Clarity Modified Ceramic Bracket is intended for use in orthodontic treatment.

Prescription Use __X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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