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

    ARGELITE A

    K Number: K934773 · Decision Dec 10, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    193
    Applicant Total
    217
    Review Days
    66

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    Basic Information

    Device Name
    ARGELITE A
    K Number
    K934773
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Argen Precious Metals, Inc.
    Date Received
    October 5, 1993
    Decision Date
    December 10, 1993
    Product Code
    EJS
    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
    EJS Alloy, Other Noble Metal

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    Other Clearances by Argen Precious Metals, Inc.

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    K961285 ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION)
    K954362 ARGISTAR 74
    K954368 ARGEDENT BIO 87 PF
    K954358 ARGENDENT GIO 86 FR
    K954404 AUROLITE 45
    K954360 ARGESOL 600
    K954371 SUREFIRE S
    Search all 217 clearances from Argen Precious Metals, Inc. →