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

    LW Retraction Cap

    K Number: K231079 · Decision Sep 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    7
    Review Days
    150

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    Basic Information

    Device Name
    LW Retraction Cap
    K Number
    K231079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ossvis Co., Ltd.
    Date Received
    April 17, 2023
    Decision Date
    September 14, 2023
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by Ossvis Co., Ltd.

    K Number Device Name
    K242703 LW Pre-milled Abutment
    K242379 LL Implant System
    K233808 LW Narrow Implant System
    K233167 LW Implant System – Abutment
    K231235 LW UCLA Abutment
    K223924 LW Implant System