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510(k) Data Aggregation

    K Number
    K221315
    Device Name
    UNIdental Symphony Implant System
    Date Cleared
    2023-10-25

    (537 days)

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

    UNIdental Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UNIdental Symphony 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The UNIdental Symphony Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
    Device Description
    The UNIdental Symphony Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy and CP Ti Grade 4 intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. Symphony 1 Fixture is Bone level, and Symphony 2 Fixture is Tissue level. Symphony 1 Fixture is a taper shape that gradually decreases the outer diameter of the lower part from the upper part. And It is a taper shape that gradually decreases the outer diameter of the lower part from the upper part. It is a structure that can perform a tapping function at the same time without a separate tap. It couples up with the abutment and its hexagon shape. Symphony 2 Fixture is a structure with a round shape at the end. It couples up with the abutment and its octagon shape. The area that touches the patient's gums is pure titanium surface. The upper structure of the abutments support prosthetics such as artificial teeth to restore patient's total mouth function.
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