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K Number
K994368
Device Name
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
Manufacturer
AMERICAN DENTAL PRODUCTS, INC.
Date Cleared
2000-03-14

(78 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 PLUS ( CARIES STAIN ) is indicated for detection of caries through the staining of the outer layer of carious dentin.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) summary for the American Dental Products Caries-Detector Plus. It states that the product's efficacy is comparable to or better than other brands on the market, as shown by third-party testing. However, it does not provide detailed information about the acceptance criteria, the specific study conducted, or any of the other information requested in the prompt.

Therefore, I cannot provide the requested information based on the given text. The document is too high-level and lacks the specific details about the study design, sample sizes, ground truth establishment, or expert involvement.

§ 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.