SUPER PORCELAIN TI-22 by NORITAKE CO., INC.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a dental porcelain product (Super Porcelain TI-22), indicating that it has been deemed substantially equivalent to a predicate device. It discusses regulatory matters, marketing permissions, and general controls, but it does not include details about device performance, acceptance criteria, or any specific studies with sample sizes, ground truth establishment, or expert involvement.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1999

Noritake Company, Incorporated C/O Ms. Marsha C. Wertzberger Counsel for Noritake Arent Fox Kintner Plotkin & Kahn 1050 Connecticut Avenue, N.W. Washington, DC 20036-5339

Re : K992024 Super Porcelain TI-22 Trade Name: Regulatory Class: II Product Code: EIH Dated: June 15, 1999 Received: June 16, 1999

Dear Ms. Wertzberger:

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 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), 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 (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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Wertzberger

through 542 of the Act for devices under the Electronic chrough 312 or cho introl provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as Info ibed in your 510 (k) premarket notification. The FDA deboring of substantial equivalence of your device to a legally marketed predicate device results in a classification for your markees 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 and additionally 809.10 for in vitro diagnostic 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 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.fda.gov/cdrh/dsma/dsmamajn.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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known) __

Device Name: Super Porcelain TI-22 and Accessories

Indications For Use:

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For use in prosthetic dentistry to create a porcelain prosthesis on a frame of titanium.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Susan Runns

(Division Sign-Off) (Division Sign-Ont)
Division of Dental, Infection Control,
Division of Devices Division... Hospital D evices 16 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.