BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AH Plus Endodontic Sealer

    K Number: K243546 · Decision Feb 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    21
    Review Days
    90

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    Basic Information

    Device Name
    AH Plus Endodontic Sealer
    K Number
    K243546
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dentsply Sirona, Inc.
    Date Received
    November 15, 2024
    Decision Date
    February 13, 2025
    Product Code
    KIF
    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
    KIF Resin, Root Canal Filling

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