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

    EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO

    K Number: K934019 · Decision Jan 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    166
    Registration Numbers
    166
    Same Product Code
    329
    Applicant Total
    4
    Review Days
    154

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    Basic Information

    Device Name
    EXCEL FORMULA HEAT-AUTO CURE DENT BASE/REPAIR/ORTHO
    K Number
    K934019
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    St. George Technology, Inc.
    Date Received
    August 17, 1993
    Decision Date
    January 18, 1994
    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 St. George Technology, Inc.

    K Number Device Name
    K023953 ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE
    K992176 EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
    K945711 EXCEL-P FORMULA AUTO-CURE DENTURE BASE