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K Number
K982773
Device Name
QUICKSET LIQUID AND POWDER
Manufacturer
SPECIALITES SEPTODONT
Date Cleared
1998-11-03

(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

Quickset™ is a quick-setting temporary restorative material.

Device Description

Quickset™ Liquid and Powder

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called "Quickset™ Liquid and Powder," which is a quick-setting temporary restorative material.

The letter states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to devices marketed prior to May 28, 1976. However, it does not provide details about:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes or data provenance for any test sets.
  • The number or qualifications of experts used to establish ground truth.
  • Adjudication methods.
  • Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
  • Whether a standalone (algorithm only) performance study was done.
  • The type of ground truth used.
  • The sample size for the training set.
  • How the ground truth for the training set was established.

This document is a regulatory clearance and not a scientific study report.

§ 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.