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510(k) Data Aggregation

    K Number
    K990367
    Device Name
    PDQ AND PDQ-TI ABUTMENT
    Manufacturer
    VIDENT
    Date Cleared
    1999-04-21

    (75 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PDQ AND PDQ-TI ABUTMENT

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

    PDQ and PDQ-Ti abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.

    Device Description

    PDQ and PDQ-Ti Abutments

    AI/ML Overview

    This is a 510(k) clearance letter from the FDA for dental abutments. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information from the provided text. The document is an administrative clearance, not a technical report detailing performance studies.

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