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510(k) Data Aggregation

    K Number
    K113430
    Device Name
    PROULTRA PIEZO ULTRASONIC
    Manufacturer
    SATELEC-ACTEON GROUP
    Date Cleared
    2012-02-23

    (94 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROULTRA PIEZO ULTRASONIC

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

    The ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with The Frookia , lead on for, scaling, periodontics, prosthesis and endodontic Dental Applications.

    Device Description

    ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator.

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental ultrasonic generator for use in scaling, periodontics, prosthesis and endodontics. It does not contain information about acceptance criteria or a study proving that a device meets those criteria. Therefore, I cannot fulfill your request based on the provided text.

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