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K Number
K970589
Device Name
MICROETCHER AP
Manufacturer
DANVILLE ENGINEERING, INC.
Date Cleared
1997-09-17

(211 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

Cutting and preparation of tooth structure, both enamel and dentin for all classes of cavity preparations. Removal of composite resin restorations. Surface roughening of enamel,dentin, and metal dental structures prior to adhesive resin bonding.

Device Description

Microetcher AP

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Microetcher Ap" and contains an FDA determination of substantial equivalence. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested table and study details. The document is an FDA clearance letter, not a study report.

§ 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.”