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510(k) Data Aggregation

    K Number
    K101332
    Device Name
    AMC-20 PORTABLE DENTAL CART MODEL AMC-20
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2011-04-11

    (334 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMC-20 PORTABLE DENTAL CART MODEL AMC-20

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

    The AMC-20 is a self-contained mobile dental cart that is used for general dentistry and endodontic applications.

    Device Description

    AMC-20 Mobile Dental Cart

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA regarding the "AMC-20 Mobile Dental Cart." It is a regulatory approval letter and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

    The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

    This means the device was approved based on its substantial equivalence to existing devices, not on a new study demonstrating its performance against specific acceptance criteria.

    Therefore, I cannot provide the requested information as it is not present in the provided text.

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