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510(k) Data Aggregation

    K Number
    K232268
    Device Name
    STERI-OSS Implant System
    Manufacturer
    Zeros Co., Ltd.
    Date Cleared
    2024-03-25

    (238 days)

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

    Zeros Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STERI-OSS Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. STERI-OSS Implant System is for single stage surgical procedures. This system is intended for delayed loading.
    Device Description
    STERI-OSS Implant System, Fixture is a medical device made of titanium that is inserted into the maxillary or mandibular alveolar bone to support prosthesis such as artificial teeth for the patient's recovery of masticatory function. STERI-OSS Implant System. Abutment is inserted to support prosthesis such as artificial teeth, and is a medical device made of titanium alloy. It connects artificial teeth with a fixture implanted in the maxillary or mandibular alveolar bone where teeth are lost.
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