CONTEC DUO, CONTEC LC, CONTEC LCR

K030644 · Dentaurum · DYH · Nov 21, 2003 · Dental

Device Facts

• Record ID: K030644
• Device Name: CONTEC DUO, CONTEC LC, CONTEC LCR
• Applicant: Dentaurum
• Product Code: DYH · Dental
• Decision Date: Nov 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3750
• Device Class: Class 2

Intended Use

ConTec: Duo, ConTec LC, ConTec LCR are adhesive compounds that are used to fix orthodontic appliance to teeth.

Device Story

ConTec Duo, ConTec LC, and ConTec LCR are adhesive resin compounds designed for bonding orthodontic appliances to tooth surfaces. Applied by dental professionals in a clinical setting, these materials facilitate the secure attachment of orthodontic hardware. The device functions as a chemical bonding agent, ensuring stability of the appliance during orthodontic treatment. Benefits include reliable fixation of orthodontic devices to enamel.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Adhesive resin and tooth conditioner. Chemical composition typical of orthodontic bonding agents. Class II device.

Indications for Use

Indicated for use as adhesive compounds to fix orthodontic appliances to teeth. Prescription use only.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal 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

NOV 2 1 2003

Ms. Jan Doorschodt General Manager Dentaurum, Incorporated 10 Pheasant Run Newtown. Pennsylvania 18940

Re: K030644

Trade/Device Name: ConTec Duo, ConTec LC, Contec LCR Regulation Number: 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: August 25, 2003 Received: August 29, 2003

Dear Ms. Doorschodt:

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 vour 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. Doorschodt

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 (OS) 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/dsma/dsmamain.html

Sincerely yours,

Q. Ls

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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Appendix 6

510(k) NUMBER (IF KNOWN):

I EVICE NAME: ConTec Duo, ConTec LC, ConTec LCR

INDICATIONS FOR USE:

ConTec: Duo, ConTec LC, ConTec LCR are adhesive compounds that are used to fix orthodontic appliance to teeth.

Super Rump

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

KO30144 510(k) Number:________________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use J (Per 21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)