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510(k) Data Aggregation

    K Number
    K173570
    Device Name
    SD Abutment
    Manufacturer
    Surgident Co., Ltd.
    Date Cleared
    2019-05-17

    (543 days)

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

    Surgident Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SD Abutment is intended for use in partially or fully edentulous maxilla, in support of single or multipleunit prosthetic restorations. SD Abutment is for single stage and two stage surgical procedures. This system is intended for delayed loading.
    Device Description
    SD Abutment made of Ti-6A1-4V ELI alloy (ASTM F136) and/or Pure Titanium Gr4 (ASTM F67) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Solid Abutment, Dual Abutment, Dual Long Abutment, Angled Abutment (15° and 25°), Temporary Abutment and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.
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    K Number
    K170697
    Device Name
    GBR system
    Manufacturer
    SURGIDENT
    Date Cleared
    2018-05-24

    (443 days)

    Product Code
    JEY, DZL
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGIDENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
    Device Description
    The GBR System is comprised of bone screws and bone plates that are used for bone fixation surgery. The bone screws and plates are not reusable. The bone screws are composed of the titanium alloy (ASTM F136) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (0.85, 1.4, 2.0 mm) and length (3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 mm). Also, the tip of screw has single type; the self-drilling and self-tapping available type and the type that require the pre-drilling (Surgeon's option). The bone plate is offered in 0.1 mm thickness and in length 22 mm x 15 mm, 36 mm x 22 mm and 44 mm x 44 mm. Each device is provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended.
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