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

    NEO DENTAL ENDODONTIC IRRIGATION SYRINGE

    K Number: K955703 · Decision May 20, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    142
    Applicant Total
    5
    Review Days
    158

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    Basic Information

    Device Name
    NEO DENTAL ENDODONTIC IRRIGATION SYRINGE
    K Number
    K955703
    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
    December 14, 1995
    Decision Date
    May 20, 1996
    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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    Other Clearances by Neodental Chemical Products Co., Ltd.

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    K971642 DENTALIS KEZ ENDODONITC SEALER