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    K Number
    K050970
    Device Name
    MILO DENTAL IMPLANT SYSTEM
    Manufacturer
    INTRA-LOCK INTERNATIONAL
    Date Cleared
    2005-10-14

    (179 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K041938,K031345,K030639
    Why did this record match?
    Device Name :

    MILO DENTAL IMPLANT SYSTEM

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

    1. MILO™ Implants are indicated for long-term maxillary and mandibular tissuesupported denture stabilization. Multiple implants may be restored after a period of time or placed in immediate function.

    2. MILO™ Implants are indicated for the rehabilitation of single and/or multiple maxillary lateral incisors. They are also indicated for the rehabilitation of single and/or multiple mandibular central and lateral incisors. The implants may be restored after a period of time or placed in immediate function.

    Device Description

    The Intra-Lock MILO™ Dental Implant System consists of machined titanium, screw-form dental implants 3.0mm in diameter. They are available in lengths of 10mm, 11.5mm, 13mm and 15mm. The implants' raw material is Titanium Alloy for Surgical Implant Applications (as per ASTM F 136 Standard Specification for Wrought Titanium-6Aluminium-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS) R56401). The implants are sterile packaged.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental implant system (Intra-Lock MILO™ Implant) and does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

    The 510(k) summary focuses on establishing substantial equivalence to predicate devices, providing a device description, intended use, and the FDA's clearance letter. It does not include the details typically found in a clinical study report or performance testing document that would describe acceptance criteria and how they were met.

    Therefore, I cannot provide the requested information based on the provided text.

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