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

    VITAPEX PRE-LOADED DENTAL SYRINGE

    K Number: K973667 · Decision Nov 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    5
    Review Days
    42

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    Basic Information

    Device Name
    VITAPEX PRE-LOADED DENTAL SYRINGE
    K Number
    K973667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3820
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neodental Chemical Products Co., Ltd.
    Date Received
    September 25, 1997
    Decision Date
    November 6, 1997
    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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    K955703 NEO DENTAL ENDODONTIC IRRIGATION SYRINGE