LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K083195
    Device Name
    MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN
    Manufacturer
    LANG DENTAL MFG. CO., INC.
    Date Cleared
    2009-06-05

    (219 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MACH 4 JET TOOTH SHADE PROVISONAL CROWN AND BRIDGE ACRYLIC RESIN

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

    LANG DENTAL TOOTH SHADE TEMPORARY CROWN AND BRIDGE ACRYLIC RESIN is intended for the fabrication of temporary crowns and bridges.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria or study data for device performance. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

    Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

    • Acceptance criteria and reported device performance.
    • Sample sizes, data provenance, or details of expert involvement for ground truth establishment.
    • Adjudication methods.
    • MRMC comparative effectiveness studies or standalone algorithm performance.
    • The type of ground truth used or details about training sets.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1