(61 days)
Fabrication of dental prostheses like: Clasps, provisional bridges, space maintainers, partials orthodontic devices and abutments.
Not Found
This looks like a 510(k) clearance letter for a dental device, "Dental D," not a study report with performance metrics.
Therefore, the provided text does not contain the information requested regarding:
- Acceptance criteria and reported device performance.
- Sample size for test set, data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for training set.
- Ground truth establishment for the training set.
The document is a regulatory letter from the FDA stating that the device is "substantially equivalent" to previously marketed devices for the fabrication of dental prostheses. It outlines the regulatory classification and general controls applicable to the device. There is no mention of a performance study or specific acceptance criteria within this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Nicolas E. Azar Director Research & Development Micro Dental Laboratories 6665 Amador Plaza Road, #200 Dublin, California 94568
K974622 Re : "DENTAL D" Trade Name: Requlatory Class: I Product Code: ЕНБ Dated: December 9, 1997 Received: December 11, 1997
Dear Mr. Azar:
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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) 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 Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531
Image /page/0/Picture/8 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
FEB 1 0 1998
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Page 2 - Mr. Azar
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,
Timothy A. Ulatowski
Timot A 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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K974622 510(k) Number (if known): Not Known
Device Name: Dental D
Indications For Use: Fabrication of dental prostheses like: Clasps, provisional bridges, space maintainers, partials orthodontic devices and abutments.
( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation ( ODE )
| Susan Bouve | |
|---|---|
| (Division Sign-Off) | |
| Division of Infection Control, and General Hospital Devices | |
| 510(k) Number | K974622 |
| Prescription Use (Per 21 CFR 801.109) | Yes |
OR Over-The-Counter Use(Optional Format 1-2-96)
§ 872.3285 Preformed clasp.
(a)
Identification. A preformed clasp or a preformed wire clasp is a prefabricated device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be incorporated into a dental appliance, such as a partial denture, to help stabilize the appliance in the patient's mouth by fastening the appliance to an adjacent tooth.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.