(48 days)
FOR USE IN PROSTHETIC DENTISTRY TO CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY .
Not Found
I'm sorry, but without further context, the provided document does not contain information on the acceptance criteria or a study proving that a device meets those criteria. The document appears to be an FDA 510(k) clearance letter for a dental device called "SUPER PORCELAIN ADDMATE", indicating it has been found substantially equivalent to a predicate device. It specifies general information about the clearance process but does not detail performance acceptance criteria or a specific study to validate them.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 NOV
Noritake Company, Incorporated C/o Ms. Marsha C. Wertzberger Counsel for Noritake Arent Fox Kintner Plotkin & Kahn 1050 Connecticut Avenue, NW Washington, DC 20036-5339
Re : K983247 Super Porcelain Addmate Trade Name: Requlatory Class: II Product Code: EIH September 16, 1998 Dated: September 16, 1998 Received:
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 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 general 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory 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 obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Wertzberger
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 leqally 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 regulation entitled, "Misbranding by reference to
premarket notification" (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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowsk Directdr 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): K983247
SUPER PORCELAIN ADDMATE Device Name: __
Indications For Use:
FOR USE IN PROSTHETIC DENTISTRY TO CREATE A PORCELAIN PROSTHESIS ON A FRAME OF DENTAL ALLOY .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NERDED)
General CORE Object Device Definition (CODD)
SDnmev
(Division Sign-Off) Division of Dontal, unfection Control, and General bospital I 510(k) Number ...
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
k..
K
(Optional Formal 1-2-96)
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02/13 '96 11:07
§ 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.