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510(k) Data Aggregation

    K Number
    K231753
    Device Name
    Oneday Implant Abutment
    Manufacturer
    Oneday Biotech Co., Ltd.
    Date Cleared
    2024-02-21

    (251 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oneday Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oneday Implant Abutment is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Implants with diameters larger than 5 mm are intended to be used in the molar region.
    Device Description
    The Oneday Implant Abutment is a material for dental surgery and is an abutment used to support and maintain prosthetic restored teeth in case of partial or total loss of teeth. It is used in combination with a fixture implanted in the jawbone.
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    K Number
    K222946
    Device Name
    Oneday Mini Implant System
    Manufacturer
    Oneday Biotech Co., Ltd.
    Date Cleared
    2023-08-23

    (330 days)

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

    Oneday Biotech Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oneday Mini Implant System is intended for two-stage surgical procedures in the following situations and with the following clinical protocols: - The intended use for the 3.0mm, 3.3mm diameter Oneday Mini Implant is limited to the replacement of maxillary lateral incisors and mandibular incisors. - Immediate placement in extraction situations with a partially or completely healed alveolar ridge. - It is intended for delayed loading.
    Device Description
    The Oneday Mini Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. 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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