CARIES FINDER by DANVILLE ENGINEERING, INC. | FDA 510(k) Summary

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K Number

Validate with FDA (Live)

Device Name

Manufacturer

DANVILLE ENGINEERING, INC.

Date Cleared

1996-02-08

(71 days)

Product Code

Regulation Number

Type

Panel

Age Range

N/A

Reference & Predicate Devices

N/A

Predicate For

Intended Use

Device Description

AI/ML Overview

Summary

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Regulation Number and Section

§ 872.1740 Caries detection device.

(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.