(82 days)
Material for making temporary crowns and bridges, self curing, fast setting, bis-acrylic-composite 2:1
Not Found
I apologize, but the provided text is a 510(k) clearance letter from the FDA for a dental material called "Tempofit," and a statement of indications for use.
This document does not contain any information about:
- Acceptance criteria for a device.
- A study that proves a device meets acceptance criteria.
- Any of the specific details requested in your prompt (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details, etc.).
The letter is simply an FDA approval notice indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications and general controls, but not performance study details.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2000
Dentax Gmbh & Company, KG c/o Mr. Barry Hale C.Q.E. Dentax Gmbh & Company, KG 7707 E 201 terr Belton, Missouri 64012
Re : K994012 Trade Name: Tempofit, Model 02693 Requlatory Class: II Product Code: EBG Dated: November 23, 2000 November 26, 2000 Received:
Dear Mr. Hale:
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, qood manufacturing practice, labelinq, 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 Regulations, Title 21, Parts 800 to 895. ਸੇ 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. Hale
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 obitgation you may the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberined in four tial equivalence of your device to a legally marketed predicate device results in a classification for your markets productorermits 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
Director
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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Statement of Indications for Use
510(k) Number(If known): K994012
Device Name: tempofit®
Indications For Use: Material for making temporary crowns and bridges, self curing, fast setting, bis-acrylic-composite 2:1
Please do not write below this line Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| Per 21 CFR 801.109 | |
| or Over-The-Counter Use | |
| Optional Format 1-2-96 |
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number _
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§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.