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510(k) Data Aggregation

    K Number
    K071213
    Device Name
    CAMLOG LOGFIT PROSTHETIC SYSTEM
    Manufacturer
    ALTATEC GMBH
    Date Cleared
    2007-08-10

    (101 days)

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

    CAMLOG LOGFIT PROSTHETIC SYSTEM

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

    The CAMLOG Logfit™ Prosthetic System is intended to be used to fabricate crowns and bridges in conjunction with CAMLOG dental implants to support prostheses in the naxillary and/or mandibular arch.

    Device Description

    The CAMLOG Logfit Prosthetic System includes dental implant abutments and screws intended to be used to support cement retained crowns and bridges in conjunction with Camlog dental implants in the maxillary and/or mandibular arch. The system also includes impression caps, analogs and plastic, burn-out copings, (Class I exempt, not a part of this submission), intended to facilitate the preparation of prosthetic restorations.

    AI/ML Overview

    This document does not contain an acceptance criteria table or a study description of the device's performance. The provided text is a 510(k) summary for the CAMLOG Logfit™ Prosthetic System, which focuses on administrative information, device description, intended use, and equivalence to predicate devices, culminating in the FDA's clearance letter.

    Therefore, I cannot provide the requested information.

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