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K Number
K981564
Device Name
AIR TECHNIQUES' AIRDENT II
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
1998-09-24

(146 days)

Product Code
KOJ
Regulation Number
872.6080
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AIRDENT II AIR ABRASION SYSTEM is designed for use by Dentists and sold through authorized Air Techniques' Dealers for the following purposes:
l-Cavity preparations for composite restorations and small amalgam fillings and preparations for aesthetic composite procedures.
2-Composite restoration removal.
3-Partial composite restoration removal and repair or rebonding at failure sites.
4-Preparation for pit and fissure sealants.
5-Etching of tooth structure and porcelain for bonding.
Acid etching materials should be used in conjunction with the AIRDENT II in bonding procedures.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text is a 510(k) clearance letter for the Air Techniques' AirDent II device. This document primarily focuses on regulatory approval and indications for use, and it does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria, as outlined in your request.

Specifically, the document does not provide any of the following:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size for test set or data provenance.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
  6. Information about standalone (algorithm-only) performance.
  7. Type of ground truth used (e.g., pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request using the provided input.

§ 872.6080 Airbrush.

(a)
Identification. An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.(b)
Classification. Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”