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

    LARES APOLLO CS/CP/C

    K Number: K905543 · Decision Mar 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    213
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    LARES APOLLO CS/CP/C
    K Number
    K905543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Lares Research, Inc.
    Date Received
    December 11, 1990
    Decision Date
    March 11, 1991
    Product Code
    EBZ
    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
    EBZ Activator, Ultraviolet, For Polymerization

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    Other Clearances by Lares Research, Inc.

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    K031540 APEX ELECTRIC HANDPIECE SYSTEM
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    K961163 LARES RESEARCH AS-1 LOWSPEED HANDPIECE
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