ETCHANT 40% by CONFI-DENTAL PRODUCTS CO.

This document is an FDA 510(k) clearance letter for a dental etching product, not a study report for a device's performance. Therefore, it does not contain the information required to answer your query.

The letter explicitly states: "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..."

This means the FDA cleared the "Etchant 40%" by determining it is "substantially equivalent" to existing products, rather than requiring a detailed study proving its performance against acceptance criteria as might be done for novel devices or software regulated as medical devices.

Therefore, I cannot provide:

A table of acceptance criteria and the reported device performance: This document does not describe performance criteria or study results for this specific product.
Sample size used for the test set and the data provenance: No test set information is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth experts are mentioned.
Adjudication method: Not applicable as no study is detailed.
Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
Standalone performance study: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three people.

Public Health Service

MAY - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen Rudolph Quality Manager Confi-Dental Products Company 416 South Taylor Avenue Louisville, Colorado 80027

Re: K030743

Trade/Device Name: Etchant 40% Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 06, 2003 Received: March 10, 2003

Dear Mr. Rudolph:

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. Stephen Rudolph

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,

Sum Runge

Susan Runner, DDS, MA Interim 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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Ver/ 3 - 4/24/96

Applicant: Confi-Dental Products Company

K030743 510K number (if known):

Device Name: Etchant 40%

Indications for Use:

Etchant 40% is indicated for the following applications:

Etchant 40% is indicated for initiation of the bonding sequence for bonding restorative materials to enamel and/or dentin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulley for MSR

(Per 21 CFR 801.109)

esthesiology, General Hospital, ction Control, Den

510(k) Number:

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.