BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL

    K Number: K972935 · Decision Jan 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    3
    Review Days
    174

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    Basic Information

    Device Name
    SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL
    K Number
    K972935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    S.S. White Mfg., Ltd.
    Date Received
    August 8, 1997
    Decision Date
    January 29, 1998
    Product Code
    EMA
    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
    EMA Cement, Dental

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    Other Clearances by S.S. White Mfg., Ltd.

    K Number Device Name
    K965083 SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
    K964179 SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS