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

    IR SLA Type Implant System

    K Number: K222144 · Decision Jun 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    6
    Review Days
    329

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    Basic Information

    Device Name
    IR SLA Type Implant System
    K Number
    K222144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotem Co., Ltd.
    Date Received
    July 20, 2022
    Decision Date
    June 14, 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 Biotem Co., Ltd.

    K Number Device Name
    K222142 BR SLA Type Implant System
    K190641 AR_N SLA Type Implant System
    K171179 BR Type Implant System
    K171297 AR_N Type Implant System
    K171185 IR Type Implant System