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510(k) Data Aggregation

    K Number
    K991946
    Device Name
    ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L
    Manufacturer
    STERILEX CORP.
    Date Cleared
    1999-09-03

    (86 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K141504
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product has been specially formulated and clinically proven to clean deposits and control bacterial contamination in Dental Unit Water Lines.

    Device Description

    Ultra-Kleen Powder for Dental Unit Water Lines, Models 513

    AI/ML Overview

    The provided text is a notification from the FDA regarding the clearance of a device, "Ultra-Kleen Powder for Dental Unit Water Lines," but it does not contain the detailed information required to answer the specific questions about acceptance criteria and the study that proves the device meets those criteria. The letter is a regulatory document confirming substantial equivalence to a predicate device, not a summary of a performance study.

    Therefore, I cannot provide the requested information from the given text. The text does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes, data provenance, or details about test sets.
    3. Information on the number or qualifications of experts, or adjudication methods.
    4. Details about multi-reader multi-case studies or effect sizes.
    5. Information about standalone algorithm performance.
    6. The type of ground truth used.
    7. Sample sizes for training sets.
    8. How ground truth for training sets was established.
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