BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    Elos Accurate Customized Abutment

    K Number: K231307 · Decision Dec 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    13
    Review Days
    230

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    Basic Information

    Device Name
    Elos Accurate Customized Abutment
    K Number
    K231307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Elos Medtech Pinol A/S
    Date Received
    May 5, 2023
    Decision Date
    December 21, 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 Elos Medtech Pinol A/S

    K Number Device Name
    K253774 Elos Accurate® Denture Fixation System
    K251497 Elos Accurate Hybrid Base
    K242025 Elos Accurate® Hybrid Base™
    K241722 Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment
    K230317 Elos Accurate Hybrid Base
    K222044 Elos Accurate Customized Abutment
    K201860 Elos Accurate Hybrid Base
    K191919 Elos Accurate Hybrid Base
    K191890 Elos Accurate Customized Abutment
    K192457 Elos Accurate Customized Abutment
    Search all 13 clearances from Elos Medtech Pinol A/S →