(79 days)
For use in prosthetic dentistry to create an all-ceramic prosthesis.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental ceramic product called "Grand Ceram." This document does not contain information related to the acceptance criteria, study details, or performance metrics of a device as typically found in a clinical or performance study report for AI/ML-based medical devices.
The letter confirms that "Grand Ceram" is substantially equivalent to a legally marketed predicate device, indicating it's a conventional material rather than a software-as-a-medical-device (SaMD) or an AI-enabled device that would require the kind of detailed performance study you're asking about.
Therefore, I cannot extract the requested information (acceptance criteria, sample sizes, ground truth establishment, MRMC study details, etc.) from this document. The document primarily focuses on regulatory clearance for a dental material based on substantial equivalence.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling a bird or a human figure with outstretched arms, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 일 후
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: K992023 Grand Ceram Trade Name: Requlatory Class: II Product Code: EIH June 15, 1999 Dated: 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 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/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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Page of of
510(k) Number (if known): __
Grand Ceram Device Name:_
Indications For Use:
For use in prosthetic dentistry to create an all-ceramic prosthesis.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runse
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices leagues 510(k) Number
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(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)
§ 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.