BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

    K Number: K212475 · Decision May 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    75
    Applicant Total
    7
    Review Days
    280

    Basic Information

    Device Name
    Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
    K Number
    K212475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3250
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prevest Denpro Limited
    Date Received
    August 6, 2021
    Decision Date
    May 13, 2022
    Product Code
    EJK
    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
    EJK Liner, Cavity, Calcium Hydroxide

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