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510(k) Data Aggregation

    K Number
    K142846
    Device Name
    BBX1, BBX2, BBX1MO, BBX1MC
    Manufacturer
    Date Cleared
    2016-09-08

    (709 days)

    Product Code
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLOBALDENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BBX1, BBX2, BBX1MO, BBX1MC dental implants are intended for immediate loading in the bone of the maxillary or mandibular arch when optimal primary stability is achieved and appropriate occlusal loading. It is intended for use as support of crown bridges and overdentures when a one stage surgical approach is applied. It is intended for the restoration of a patient's chewing function.
    Device Description
    BBX1, BBX1MO, BBX1MC and BBX2 dental implants whose material composition of the implants is titanium alloy Grade 5 ELI (Titanium 6 AL 4V), conforming to ASTM F-136 (Stundard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Surface treatment features include air blasting with Biphasic Calcium Phosphate (CaPO4) and HA micro particles, followed by acid passivation and cleaning, conforming to ASTM F1088 Surface Treatment HA, ASTM F-86 (Passivation), and ASTM F1185-03 Trace Elements. BBX1, BBX1MQ, BBX1MC and BBX2 dental implants are all provided with screw thread and helix shape inclined grooves. For dental implant series BBX1, BBX1MC, the shoulder or abutment is integrated, that is, not a separate part of the whole implant. They are one piece dental implants. Dental implants series BBX2 consists of three parts, one straight abutment, one screw and the implant body. BBX1, BBX2, BBX1MO and BBX1MC dental implants consist of a threaded area, a transgingival area, mini threads, an implant body area and a vertical abutment.
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