(28 days)
- temporary cementing of temporary crowns and bridges
- temporary cementing of final restorations
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria.
The document is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG regarding their device, TempoSil. It confirms that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (temporary cementing of temporary crowns and bridges, and temporary cementing of final restorations).
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Information about specific studies conducted, sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Details about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
The letter primarily focuses on regulatory approval based on "substantial equivalence" rather than presenting detailed study results.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
MAR 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Coltene/Whaledent AG C/O Mr. Henry J. Vogelstein Consultant 1349 Lexington Avenue New York, New York 10128
Re: K050426
Trade/Device Name: TempoSil Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: February 17, 2005 Received: February 18, 2005
Dear Mr. Vogelstein:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass batted in also increations and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be frant of other of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 – Mr. Henry J. Vogelstein
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1177 s 155dailed of a vace ince complies with other requirements of the Act or that FDA made a decemination that your certify of ther Federal agencies. You must comply with any Federal statutes and regulations administration of to: registration and listing (21 CFR Part 807); an the Act s requirements; morading; base ring practice requirements as set forth in the quality labeling (21 CFR Part 801), good manazave.org from if applicable, the electronic product radiation systems (QB) regallers (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter whil anow you to oegin manteting your antial equivalence of your device to a legally premarked notification: "The PDF mailig of bation 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), please If you desire specific daries in: Joan at (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Comphilance an (21 CFR Part 807.97). You may obtain other Mission of reference to promobilities under the Act from the Division of Small general international on your copyright in the many of its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suyette Michie, Om.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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coltène
whaledent
Coltène/Whaledent AG 510(k) Submission TempoSil Indications for use
Indications for use
510(k) Number (if known): more |(05 0 426
Device Name:
TempoSil
and/or
Indications for use:
- temporary cementing of temporary crowns and bridges - temporary cementing of final restorations
Prescription Use: __ × (21 CFR Part 801 Subpart D) Over-the Counter Use: _ (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russer
al Ser Off on of Ancoflestology, General Hospital, Jon Control, Dental Devices
10 100 KOS 04264260
§ 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.