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510(k) Data Aggregation

    K Number
    K992435
    Device Name
    BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
    Manufacturer
    AZO ENTERPRISES
    Date Cleared
    1999-10-15

    (85 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AZO ENTERPRISES

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

    This device is intended to clean and sanitize toothbrushes before and after normal oral use.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "Toothbrush Mate." This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as described in the prompt.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided text. The document is a regulatory approval letter, not a study report.

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