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

    LOOP LED Curing Light System

    K Number: K200775 · Decision Aug 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    213
    Applicant Total
    2
    Review Days
    142

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    Basic Information

    Device Name
    LOOP LED Curing Light System
    K Number
    K200775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.6070
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Garrison Dental Solutions, LLC
    Date Received
    March 25, 2020
    Decision Date
    August 14, 2020
    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 Garrison Dental Solutions, LLC

    K Number Device Name
    K241238 LOOP™ LED Curing Light System (CLK01)