FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

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K Number

K955445

Device Name

CARIES FINDER

Manufacturer

DANVILLE ENGINEERING, INC.

Date Cleared

1996-02-08

(71 days)