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510(k) Data Aggregation

    K Number
    K052574
    Device Name
    COMPACT PLUS - EXTREME - PERFECT PLUS
    Manufacturer
    J.O. SUAREZ & CIA, LTDA
    Date Cleared
    2006-07-17

    (301 days)

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

    THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.

    Device Description

    THESE DENTAL CHAIRS ARE AC-POWERED AND INTENDED TO PROPERLY POSITION A PATIENT TO PERFORM ROUTINE DENTAL PROCEDURES. ITS ATTACHED operative dental unit is intended to serve as a base for other dental DEVICES, SUCH AS DENTAL HAND PIECES, AIR OR WATER SYRINGE UNIT ANC OTHER DENTAL DEVICES AND ACCESSORIES. THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a dental operative unit. This type of document is a regulatory approval letter and does not contain acceptance criteria or study details regarding the performance of an AI/ML powered medical device.

    The device described, "Compact Plus, Perfect Plus, Extreme Operative Dental Unit," is a dental chair and an attached operative dental unit intended to properly position a patient for routine dental procedures and serve as a base for other dental devices. It explicitly states, "THESE DENTAL UNITS DO NOT HAVE ANY INSTRUMENT OR DEVICE THAT MAY BE USED ON THE PATIENT."

    Therefore, it is a physical medical device, not an AI/ML powered device, and the information requested pertaining to AI/ML model performance, ground truth, expert adjudication, or comparative effectiveness studies is not applicable and cannot be extracted from this document.

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