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510(k) Data Aggregation

    K Number
    K243002
    Device Name
    MBA Biotech Implant System
    Manufacturer
    MBA Biotech Co., Ltd.
    Date Cleared
    2025-06-06

    (253 days)

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

    MBA Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MBA Biotech Implant 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Wide Fixture System is intended to be used in the molar region.
    Device Description
    The MBA Biotech Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of teeth. It is two stage endosseous screw type implant with internal hexagonal connection. This system consists of the fixture, cover screw, and various abutments. Only the subject abutments can be used with the subject fixtures. The Fixture is made of Pure Titanium of ASTM F67 and the surface of the fixture is treated with the SLA(Sand-blasted, Large grit, Acid-etched surface). Fixture is provided sterile.
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