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510(k) Data Aggregation

    K Number
    K063768
    Device Name
    TITANIUM SCALLOPED ABUTMENT
    Manufacturer
    VIDENT
    Date Cleared
    2007-06-27

    (189 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TITANIUM SCALLOPED ABUTMENT

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

    The Titanium Scalloped abutments are designed for use with Nobel Biocare® Brånemark™ external hex, 31™ external hex and Zimmer® internal hex 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 cemented onto the abutment. The abutments are indicated for full arch or partially endentulous patient restoration including single implant restorations,

    Device Description

    Titanium Scalloped Abutment

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to VIDENT regarding their Titanium Scalloped Abutment. It confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The document is a regulatory approval notice, not a study report. Therefore, I cannot extract the requested information from this text.

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