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510(k) Data Aggregation

    K Number
    K983727
    Device Name
    BIOSONIC ULTRASONIC SCALER SYSTEM
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    1999-01-20

    (90 days)

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

    BIOSONIC ULTRASONIC SCALER SYSTEM

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

    Ultrasonic applications for: All subgingival and supra gingival scaling, Periodontal therapy, and routine prophylaxis procedures

    Device Description

    BioSonic Ultrasonic Scaler System

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA for a device called "BioSonic Ultrasonic Scaler System". This document does not describe acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or any of the other specific details requested in the prompt about a clinical study for a medical device.

    The letter is an approval notification for marketing the device based on its substantial equivalence to a legally marketed predicate device, not a report on the results of a contemporary performance study.

    Therefore, I cannot fulfill the request using only the provided text. The requested information is not present in this document.

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