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510(k) Data Aggregation

    K Number
    K983077
    Device Name
    BIO PONTOSTAR
    Manufacturer
    BEGO U.S.A.
    Date Cleared
    1998-10-23

    (51 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIO PONTOSTAR

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

    Bio PontoStar is a metal to ceramic type 4 alloy. I is a medical device in accordance with Regulation 93/42 EEC. Class Iia according to Annex IX.

    Device Description

    Bio PontoStar is a metal to ceramic type 4 alloy.

    AI/ML Overview

    This document is a marketing authorization letter from the FDA for a dental alloy device (Bio PontoStar). It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

    Therefore, I cannot answer your request based on the provided text. The document confirms that the device is "substantially equivalent" to previously marketed devices, allowing it to be sold, but it does not detail the technical performance evaluations.

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