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

    POWDERLITE

    K Number: K760369 · Decision Aug 11, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    14
    Review Days
    7

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    Basic Information

    Device Name
    POWDERLITE
    K Number
    K760369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    The S. S. White Co.
    Date Received
    August 4, 1976
    Decision Date
    August 11, 1976
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

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    Other Clearances by The S. S. White Co.

    K Number Device Name
    K852745 PORCELAIN VENEER SYSTEM BONDING KIT
    K852744 CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR
    K853005 S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM
    K852743 PORCELAIN VENEER SYSTEM LABORATORY KIT
    K852182 EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER
    K837440 UNKNOWN
    K827816 PODIATRY X-RAY UNIT
    K781293 RESTORATIVE SYSTEM PROFILE
    K771938 ALGINATE IMPRESSION MATERIAL
    K770093 DENTAL BURS
    Search all 14 clearances from The S. S. White Co. →