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K Number
K973092
Device Name
STAE
Manufacturer
SOUTHERN DENTAL INDUSTRIES, INC.
Date Cleared
1997-12-08

(112 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Dentin and Enamel adhesive for use with resin based restorative materials.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental adhesive named "STAE." It confirms that the device is substantially equivalent to legally marketed predicate devices.

This document does not contain any information about:

  • Acceptance criteria or reported device performance in a table format.
  • Sample sizes for test sets or their data provenance.
  • Number or qualifications of experts used for establishing ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Standalone algorithm performance studies.
  • Types of ground truth used (e.g., pathology, outcomes data).
  • Sample sizes for training sets.
  • How ground truth for training sets was established.

The letter is purely a regulatory approval document and does not detail the technical studies or performance data that would have been submitted as part of the 510(k) application.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.