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K Number
K053565
Device Name
TEMPBOND CLEAR WITH TRICLOSAN
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
2006-02-03

(43 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

TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, transparent, resin-based cernent with triclosan designed to be used in conjunction with temporary restorations such as crowns, bridges, inlays, onlays and splints.

Device Description

TempBond Clear with Triclosan is a dual-cured, temporary, eugenol-free, resin-based cement with triclosan. This base/catalyst cement is flexible and transparent when cured. The device will be packaged in a dual-barrel syringe to eliminate hand mixing. It has excellent flow to permit the restoration to be easily and completely seated. It is strong enough to withstand the stresses of mastication, yet permits easy removal of the restoration when it is desired. TempBond Clear with Triclosan contains triclosan.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or comparative effectiveness.

This document is a 510(k) premarket notification for a dental product called "TempBond Clear with Triclosan." It describes the device, its intended use, and claims substantial equivalence to another legally marketed device (Kerr Corporation, TempBond Clear). The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot fulfill your request for the following reasons:

  • No acceptance criteria: The document does not define any specific acceptance criteria for performance metrics (like sensitivity, specificity, or accuracy) that would be relevant for an AI/ML device.
  • No study to prove device meets acceptance criteria: There is no study described that evaluates the performance of "TempBond Clear with Triclosan" against any set criteria. The approval is based on substantial equivalence to a predicate device, not on direct performance testing against clinical endpoints or statistical metrics relevant to AI.
  • No information on AI/ML components: The device described is a dental cement, not an AI-powered diagnostic or therapeutic tool. Therefore, concepts like sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are irrelevant to this submission.

In summary, the provided text is a regulatory submission for a conventional medical device (dental cement) and does not involve AI/ML or the types of performance studies you've inquired about.

§ 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.