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

    EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA

    K Number: K853094 · Decision Apr 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    6
    Review Days
    255

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    Basic Information

    Device Name
    EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA
    K Number
    K853094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Psp Dental Co., Ltd.
    Date Received
    July 23, 1985
    Decision Date
    April 4, 1986
    Product Code
    EBI
    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
    EBI Resin, Denture, Relining, Repairing, Rebasing

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    Other Clearances by Psp Dental Co., Ltd.

    K Number Device Name
    K853089 SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE
    K853092 PSP C & B TEMP
    K853091 CARDCHEM AQUASET, TEMP D, TEMPLIN, 2N PHOSPHATE
    K853090 CERAMCHEM, CERAMFIL B, STRATICEM, FLURICEM, FLORIO
    K853093 PSP TEMP - TRAY