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K Number
K030807
Device Name
CARIES INDICATOR
Manufacturer
CONFI-DENTAL PRODUCTS CO.
Date Cleared
2003-06-09

(88 days)

Product Code
LFC
Regulation Number
872.1740
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Caries Indicator is indicated for the following applications: Designed to be used to help identify caries in dentin.

Device Description

Not Found

AI/ML Overview

This FDA letter confirms substantial equivalence for a Caries Indicator device (K030807), but it does not contain any information about acceptance criteria or a study proving the device meets said criteria.

The letter is a regulatory document affirming that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include performance data or details of clinical studies.

Therefore, I cannot provide the requested information based on the provided text.

§ 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.