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510(k) Data Aggregation

    K Number
    K151626
    Device Name
    ET III Bio-SA Fixture System
    Manufacturer
    HiOSSEN Inc.
    Date Cleared
    2016-07-21

    (400 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K112532,K123784
    Why did this record match?
    Device Name :

    ET III Bio-SA Fixture System

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

    ETIII Bio-SA Fixture System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including ; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The ETIII Bio-SA Fixture System is for single and two stage surgical procedures. It is intended for delayed loading.

    Device Description

    ETIII Bio-SA Fixture has features of single threads, internal hex connection, taper body, and Bio-SA surface treatment. ETIII Bio-SA Fixture System is permanent dental implant made with Pure titanium Grade 4 (ASTMF67-06). The proposed device is sandblasted, acid etched, coated with calcium phosphate by immersing and then finally coated with hydrophilic materials (glucose and NaCl with saline concentrations).

    AI/ML Overview

    The provided text is a 510(k) summary for a dental implant system (ETIII Bio-SA Fixture System) and does not contain information about an AI/ML-driven medical device. Therefore, it does not describe acceptance criteria, a study proving an AI device meets those criteria, or other details typically associated with the evaluation of AI/ML performance.

    The document discusses:

    • Device Description: An endosseous dental implant system made of pure titanium, with specific design features and surface treatment.
    • Intended Use: For partially or fully edentulous mandibles and maxillae to support various dental restorations.
    • Predicate Devices: Comparison with existing dental implant systems, highlighting the key difference of an added hydrophilic coating for improved wettability.
    • Non-Clinical Testing:
      • Wettability and blood affinity observations.
      • Surface analysis (EDS, FE-SEM, ICP-AES).
      • Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, chromosome aberration, implantation, pyrogenicity) conducted according to ISO and FDA guidelines.
      • Animal study (Beagle dogs): Measured removal torque, bone loss, and bone-to-implant contact.
    • Clinical Testing: A study with 45 subjects and 66 implants, evaluating primary stability, bone resorption, complications, and other factors, reporting a 100% success rate after 16.3 months average follow-up.
    • Shelf-life validation and sterilization.

    Summary of missing information relevant to AI/ML device evaluation:

    Since this document pertains to a physical dental implant device and not an AI/ML-driven device, it does not contain any of the requested information regarding AI/ML performance criteria or studies.

    Therefore, I cannot populate the table or answer the specific questions about AI/ML device acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance.

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