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510(k) Data Aggregation

    K Number
    K060860
    Device Name
    TURKOM-CERA
    Manufacturer
    DENTAL SUPPLIERS OF AMERICA, INC.
    Date Cleared
    2006-05-19

    (51 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Turkom-Cera fused alumina copings are indicated for use as core structures of an artificial prosthesis, i.e., a three unit bridge, long bridges, full mouth bridges, for partially endentulous patients in the need of prosthetic oral reconstruction in order to restore chewing function.

    The copings are also indicated for use as single crowns that will be cemented to a natural or an artificial tooth abutment in the treatment of partially endentulous patients in order to restore chewing function.

    Device Description

    Turkom-Cera (Coping for porcelain teeth)

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the Turkom-Cera device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It defines the indications for use but does not present any performance study data or acceptance criteria that would typically be associated with such a study.

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