(91 days)
TempoCem is a dental luting agent for the temporary cementation of provisional crowns and bridges.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Foremost Dental Mfg, Incorporated regarding their device, TempoCem. This letter confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to the market.
However, the document does not contain any information about acceptance criteria or the study that proves the device meets those criteria.
The document primarily focuses on:
- The FDA's determination of substantial equivalence.
- Regulatory classification of the device (Class II).
- General controls provisions of the Act that apply to the device.
- Instructions for the manufacturer regarding labeling and promotion inquiries.
- Indications for use for TempoCem (temporary cementation of provisional crowns and bridges).
Therefore, I cannot provide the requested information as it is not present in the given text.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three wavy lines extending upwards, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Mr. D. Tim Wolf Regulatory Affairs Manager Foremost Dental Mfq, Incorporated " 242 - South Dean Street Englewood, New Jersey 07631
Re : K970775 TempoCem (Multiple) Trade Name: Regulatory Class: II Product Code: EMA Dated: April 25, 1997 Received: April 29, 1997
Dear Mr. Wolf:
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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register.
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Page 2 - Mr. Wolf
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 requlations.
This letter will allow you to begin marketing your device as a 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4692. advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral 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 pr (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
U. Glatard
Timotby 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
5 10(k) Number (il known): ___________________________________________________________________________________________________________________________________________________
TEMPOCEM Device Name: (Multiple)
Indications Iror Use:
TempoCem is a dental luting agent for the temporary cementation of provisional crowns and bridges.
Federal law restricts this device to sale by, or on the order of a dentist, or other practitioner licensed by the law of the state in which he or she practices to use or order the use ofthis device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED!
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. KA70775
Prescription Use
(Per 21 CFR 801. 109)
OR
Over-The-Counter Use No
(Optional Format 1-2-96)
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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 § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.