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

    ALGINATE/SILICONE CROWN & BRIDGE MATER

    K Number: K802990 · Decision Feb 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    401
    Applicant Total
    11
    Review Days
    70

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    Basic Information

    Device Name
    ALGINATE/SILICONE CROWN & BRIDGE MATER
    K Number
    K802990
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3660
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Buffalo Dental Mfg. Co., Inc.
    Date Received
    November 24, 1980
    Decision Date
    February 2, 1981
    Product Code
    ELW
    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
    ELW Material, Impression

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    Other Clearances by Buffalo Dental Mfg. Co., Inc.

    K Number Device Name
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    K841323 FUZZY TRAY
    K841490 POLYSULFIDE CUSTOM TRAY MATERIAL
    K820489 ULTRAFINE TRAY ADHESIVE
    K820216 ULTRA-WET
    K802882 HYDROCOLLOID COMPATIBLE CREAM ALGINATE
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