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510(k) Data Aggregation

    K Number
    K152830
    Device Name
    K3
    Manufacturer
    OSSTEM IMPLANT CO.,LTD.
    Date Cleared
    2017-04-20

    (569 days)

    Product Code
    EIA, OSS
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSTEM IMPLANT CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K3 is intended to supply power to and serve as a base for dental devices and accessories. This product includes a dental chair. The dental treatment unit is intended for use in the dental clinic environment and is used by trained dentists and/or dental assistants.
    Device Description
    K3, Dental Unit and Chair, is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with ISO 7494-1, ISO 7494-2 and ISO 6875. The 3way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel K3 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate devices.
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    K Number
    K161103
    Device Name
    US SA Implant System
    Manufacturer
    OSSTEM IMPLANT CO.,LTD.
    Date Cleared
    2017-02-02

    (289 days)

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

    OSSTEM IMPLANT CO.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The US SA 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. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as bridges, or overdenture.
    Device Description
    The US SA Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. The US Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration.
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