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

    ARGILITE 3

    K Number: K904467 · Decision Oct 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    0
    Applicant Total
    217
    Review Days
    30

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    Basic Information

    Device Name
    ARGILITE 3
    K Number
    K904467
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3060
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Argen Precious Metals, Inc.
    Date Received
    October 1, 1990
    Decision Date
    October 31, 1990
    Product Code
    EIT
    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
    EIT Applicator, Rapid Wax, Dental

    Other Clearances by Argen Precious Metals, Inc.

    K Number Device Name
    K965216 ARGI-SATIN OR OPTI0-STAR
    K961352 285 SL
    K961211 ARGELITE 52+
    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. →