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510(k) Data Aggregation

    K Number
    K062732
    Device Name
    TOMAS PIN 6 MM
    Manufacturer
    DENTAURUM
    Date Cleared
    2006-10-25

    (42 days)

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

    TOMAS PIN 6 MM

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

    To provide a fixed anchorage point for attachment of orthodontic appliances.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental implant, not a study describing acceptance criteria and device performance. Therefore, I cannot extract the requested information. The letter confirms that the TOMAS Pin 6mm device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain details about a study with acceptance criteria, sample sizes, ground truth establishment, or expert involvement.

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