(52 days)
Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.
Not Found
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy named "V-Supragold." It confirms substantial equivalence and allows the marketing of the device.
This document does not contain information about:
- Acceptance criteria and reported device performance in a numerical table.
- Details of a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set specifics).
Therefore, I cannot fulfill your request for this specific information based on the text provided.
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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 consists of a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 6 1999
Mr. Kenneth A. Putney Vice President, General Manager Official Correspondent Metalor Dental USA Corporation 255 John L. Dietsch Boulevard, P.O. Box 255 North Attleborough, Massachusetts 02761-0255
Re: K993507 Trade Name: V-Supragold Requlatory Class: II Product Code: EJT Dated: October 11, 1999 Received: October 15, 1999
Dear Mr. Putney:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The qeneral controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation che rol provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your tial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate aroits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in rogandiagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 ene regation" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaygov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K993507 |
|---|---|
| --------------------------- | --------- |
Page of of
V-Supragold Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.
(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 (Optional Format 1-2-96)
Susan Runo
(Division Sign-Off) ર્યું. (Division of Dental, Infection Control, and General Hospital Devices of 2 510(k) Number -
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§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are 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.