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510(k) Data Aggregation

    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
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS

    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.

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