SUPERBOND by AMERICAN DENT-ALL, INC.

This document is an FDA 510(k) clearance letter for a dental alloy named "Superbond". It's a regulatory approval, not a scientific study report describing acceptance criteria and device performance in the way you've outlined. Therefore, I cannot extract the requested information from the provided text.

The document primarily focuses on:

Device identification: Superbond, a Ceramic Dental Casting Alloy.
Regulatory classification: Class II, Product Code EJH.
Substantial equivalence determination: The FDA found it substantially equivalent to legally marketed predicate devices.
Intended use: For use in Dental Laboratories, suitable for use in the fabrication of metal-ceramic dental restoration.
Regulatory compliance: Information about general controls provisions and other FDA regulations.

It does not contain any information about:

Specific acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity).
Results of a study proving the device meets acceptance criteria.
Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
MRMC studies or standalone algorithm performance.
Ground truth types or training set details.

To address your request, a different type of document, such as a clinical study report, a technical performance study report, or the 510(k) summary (which sometimes includes more detail on performance data if applicable to the device type), would be needed.

Summary

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Image /page/0/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 with three lines representing its body and wings. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

MAR 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Philip Hacopians Ouality Systems Manager American Dent-All, Incorporated 5140 San Fernando Road Glendale, California 91204

Re: K030161

Trade/Device Name: Superbond Regulation Number: 21 CFR 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Codes: EJH Dated: December 11, 2002 Received: January 16, 2003

Dear Mr. Hacopians:

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. Philip Hacopians

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 (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,

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

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Indications for Use

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510(k) Number (if known):_K030161

Device Name: ___Superbond

Indications for Use: Superbond (Ceramic Dental Casting Alloy) is for the use in Dental Laboratories, suitable for use in fabrication of metal-ceramic dental restoration.

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

Ken Wibley for MSR

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

510(k) Number. K030161

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3710 Base metal alloy.

(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.