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510(k) Data Aggregation

    K Number
    K081751
    Device Name
    ADIN DENTAL IMPLANTS SYSTEM
    Manufacturer
    ADIN DENTAL IMPLANTS SYSTEM LTD
    Date Cleared
    2008-12-19

    (183 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    K112440,K112585,K140293,K212775
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

    Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading

    Device Description

    Not Found

    AI/ML Overview

    I am unable to answer this question. The provided document is a 510(k) clearance letter for a dental implant system. It does not contain information about acceptance criteria or a study proving the device meets said criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

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