DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT by DENTAURUM

Considering the provided text, which is an FDA 510(k) clearance letter for a dental orthodontic cement, it's important to understand that this type of document does not contain the information requested in your prompt regarding acceptance criteria, study details, and data provenance for a medical device's performance evaluation.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting detailed clinical study results or performance against specific acceptance criteria in the format you've outlined. The letter confirms that the device is substantially equivalent for its stated indications for use.

Therefore, I cannot extract the requested information from the provided text. The document is an administrative clearance, not a technical report or study summary.

To answer your prompt, I would expect to see a safety and effectiveness summary, clinical study report, or similar technical documentation that describes the device's performance characteristics and how they were evaluated.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 7 2003

Mr. Jan W.A. Doorschodt General Manager Dentaurum, Incorporated 10 Pheasant Run Newtown, Pennsylvania 18940

Re: K032195

Trade/Device Name: Dentaurum GlasTec Dental Orthodontic Cement Regulation Number: 21 CFR 872.3750 Regulation Name: Bracket Adhesive Resin and Tooth Conditioner Regulatory Class: II Product Code: DYH Dated: July 09, 2003 Received: August 05, 2003

Dear Mr. 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 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. Jan W.A. 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 (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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours, ·

Ques

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

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1/03/2195 510 (k) NUMBER (IF KNOWN):

DEVICE NAME: Dentaurum GlasTec Dental Orthodontic Cement

INDICATIONS FOR USE:

Dentaurum GlasTec Dental Orthodontic Cement is a dental glass ionomer cement used to cement orthodontic bands to tooth surfaces.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109 OR

Over-The-Counter Use

Susan Runn

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Sentian of Anesthesiology, General Devices Division of Anesthoon Control. Dental

510(k) Number:

Regulation Number and Section

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a)
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.(b)
Classification. Class II.