LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K103158
    Device Name
    STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
    Manufacturer
    ANGSTROM MFG., INC.
    Date Cleared
    2011-02-07

    (104 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This Device is to be used by a Dental Hygienist for cleaning procedures on teeth. For the coupling of Disposable Prophy Angles to Dental Handpiece motors.
    Prescription Use: Used by dental Professional Only
    Over the Counter Use: No

    Device Description

    DPA Attachment Twist/Flex Adapter

    AI/ML Overview

    I am sorry but this document is a 510(k) clearance letter from the FDA for a dental device (DPA Attachment Twist/Flex Adapter). It primarily addresses the regulatory approval process and includes an "Indications for Use" statement.

    I am unable to find the requested information in the document provided, in particular there is no mention of:

    1. Acceptance criteria or device performance results.
    2. Details on sample sizes, data provenance, or ground truth establishment for any studies.
    3. Information on expert involvement, adjudication methods, or multi-reader multi-case studies.
    4. An effect size of how much human readers improve with AI vs without AI assistance.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1