BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    MegaGen Dental Implant Systems Portfolio - MR Conditional

    K Number: K230618 · Decision Oct 11, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    32
    Review Days
    219

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    Basic Information

    Device Name
    MegaGen Dental Implant Systems Portfolio - MR Conditional
    K Number
    K230618
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Megagen Implant Co., Ltd.
    Date Received
    March 6, 2023
    Decision Date
    October 11, 2023
    Product Code
    DZE
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DZE Implant, Endosseous, Root-Form

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    Other Clearances by Megagen Implant Co., Ltd.

    K Number Device Name
    K251232 MegaGen Zygoma Dental Implant System
    K242030 MegaGen Dental Implant Abutment
    K241972 BLUEDIAMOND IMPLANT
    K234142 TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
    K240754 N2
    K233450 MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw
    K231967 ARi ExCon Implant System
    K223909 R2GATE Lite TM
    K223339 Bone Chamber Implant
    K211556 N2
    Search all 32 clearances from Megagen Implant Co., Ltd. →