LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K050208
    Device Name
    FRIADENT ESTHETICAP
    Manufacturer
    DENTSPLY INTERNATIONAL
    Date Cleared
    2005-06-14

    (137 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K974628,K013867,K023113
    Why did this record match?
    Device Name :

    FRIADENT ESTHETICAP

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

    FRIADENT® EsthetiCap is an anatomically shaped abutment used for fabrication of screw-retained or cementable temporary crowns or bridges. The FRIADENT® EsthetiCap is a short-term provisional abutment for esthetic shaping of soft tissue.

    Device Description

    The FRIADENT® EsthetiCap abutments create anatomic, esthetic peri-implant gingival contours by simple customization. FRIADENT® EsthetiCap abutments are available in five diameters (3.4 mm - 6.5 mm) and two shapes (oval and triangular) that reproduce the crosssection of the tooth at the cementum-enamel junction (CEJ).

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental device, the FRIADENT® EsthetiCap. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a regulatory submission for substantial equivalence based on comparison to predicate devices, not a study reporting performance metrics or clinical outcomes. It focuses on device description, intended use, and technological characteristics compared to previously cleared devices.

    Therefore, I cannot provide the requested information from the given input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1