BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VITALLIUM WIRE

    K Number: K872746 · Decision Jul 21, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    2
    Applicant Total
    19
    Review Days
    8

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    Basic Information

    Device Name
    VITALLIUM WIRE
    K Number
    K872746
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3285
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Austenal Dental, Inc.
    Date Received
    July 13, 1987
    Decision Date
    July 21, 1987
    Product Code
    EJW
    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
    EJW Clasp, Wire

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    Other Clearances by Austenal Dental, Inc.

    K Number Device Name
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    K880875 VITALLIUM EQUIPOISE ALLOY
    K871849 LIGHT CURE DENTURE GLAZE
    K863630 AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL
    K862557 AUSTENAL ACUSOFT SOFT LINER
    K865025 AUSTENAL CONDENSING INSTRUMENT
    K864826 A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY)
    K862856 PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR
    K862667 COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY
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