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K Number
K050426
Device Name
TEMPOSIL, MODEL 6720
Manufacturer
COLTENE/WHALEDENT AG
Date Cleared
2005-03-18

(28 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • temporary cementing of temporary crowns and bridges
  • temporary cementing of final restorations
Device Description

Not Found

AI/ML Overview

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.

§ 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.