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510(k) Data Aggregation

    K Number
    K973185
    Device Name
    AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
    Manufacturer
    AMERICAN DENTAL PRODUCTS, INC.
    Date Cleared
    1997-11-14

    (81 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HB-35 DESENSITIZER USE WITH FLUORIDE FOR SENSITIVE TEETH

    Device Description

    Not Found

    AI/ML Overview

    The provided text is for a 510(k) summary for a dental desensitizer product and does not contain the information requested about acceptance criteria or a study proving device performance in the context of an AI/human-in-the-loop system.

    The document discusses:

    • A 510(k) summary for a dental desensitizer with fluoride (HB-35 Desensitizer with Fluoride).
    • Claims of comparable efficacy to other market brands based on "third-party testing" (without providing details of the testing).
    • Safety information related to its ingredients (Fluoride, Quals) and handling instructions.
    • The FDA's decision of substantial equivalence to pre-amendment devices, allowing it to be marketed.

    Therefore, I cannot populate the table or provide the requested details because the information is not present in the given text. This submission is for a traditional medical device, not an AI-powered diagnostic or assistive technology.

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