(115 days)
Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. Not for OTC use.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or details of a study that proves a device meets acceptance criteria. The document is a 510(k) premarket notification approval letter for a dental device called "Dinabase™", indicating that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It also includes the intended use of the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given information.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Les Heimann · Director of Quality Sultan Chemists, Incorporated 85 West Forest Avenue Englewood, New Jersey 07631
JUL 21 1997
K971138 Re : Dinabase™ Trade Name: Regulatory Class: II EBI Product Code: Dated: June 10, 1997 Received: June 11, 1997
Dear Mr. Heimann:
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, Drug, 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 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 requirement, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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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) 594-4618. 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,
Gilchrist
thv 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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ATTACHMENT #4 REVISED INDICATIONS FOR USE
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ORIG
VIII. i Indications for Use: {Separate Page}
K971138 510(k) Number: NA
Device Name: DINABASE™
Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. ................. Not for OTC use.
(PLEASE DO NOT WRITE BBLOW THIS LINE--CONTINUE ON ANOTHER PAGE IF WERDBU
Concurrence of CDRH, Office of Device Evaluation(ODB)
(Division Sign-Off) R SBESC Division of Dental, Infection Control, and Ganera! Hospital Devic 510(k) Number _ ary K Prescription Use OR (Per 2) CFR 801.109
Over-The-Counter Use (Optional Pormat 1-2-96)
epl p. }
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.