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K Number
K083304
Device Name
TEMPOSIL 2
Manufacturer
COLTENE/WHALEDENT AG
Date Cleared
2009-02-06

(88 days)

Product Code
EMA
Regulation Number
872.3275
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TempoSIL 2 is indicated for

  • temporary cementation of provisional restorations
  • temporary cementation of provisional restorations on implant abutments
  • temporary cementation of final crown and bridges
  • temporary cementation of final crowns and bridges on implant abutments
Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any acceptance criteria.

The document is a 510(k) premarket notification letter from the FDA to Coltene/Whaledent AG for a dental cement called "Temposil 2". It states that the device is substantially equivalent to legally marketed predicate devices. The letter primarily focuses on regulatory compliance, outlining the requirements for marketing the device under the Federal Food, Drug, and Cosmetic Act.

The document includes:

  • The trade/device name: Temposil 2
  • Regulation Number and Name: 872.3275, Dental Cement
  • Regulatory Class: II
  • Product Code: EMA
  • Date of FDA review and receipt of the notification.
  • A confirmation of substantial equivalence.
  • A list of general controls and additional controls the device may be subject to.
  • Contact information for various FDA offices.
  • The Indications for Use statement for TempoSIL 2.

There is no mention of:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes for a test set or data provenance.
  3. Number and qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Standalone algorithm performance studies.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 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.