BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    CU-100A LIGHT CURE UNIT

    K Number: K980792 · Decision May 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    204
    Same Product Code
    931
    Applicant Total
    12
    Review Days
    74

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CU-100A LIGHT CURE UNIT
    K Number
    K980792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3690
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Rolence Enterprise Co. , Ltd.
    Date Received
    March 2, 1998
    Decision Date
    May 15, 1998
    Product Code
    EBF
    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
    EBF Material, Tooth Shade, Resin

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.

    SRGC-06

    FDA 510(k)
    FDA Class 2 ·Dental

    DIAFIL

    FDA 510(k)
    FDA Class 2 ·Dental

    DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)

    FDA 510(k)
    FDA Class 2 ·Dental

    Dual Core

    FDA 510(k)
    FDA Class 2 ·Dental

    Dura-Crown

    FDA 510(k)
    FDA Class 2 ·Dental

    Grandio disc multicolor

    FDA 510(k)
    FDA Class 2 ·Dental
    View all

    Other Clearances by Rolence Enterprise Co. , Ltd.

    K Number Device Name
    K001719 Q-LUX PLASMA 100 LIGHT CURE UNIT
    K991865 Q-LITE 75 LIGHT CURE UNIT
    K991863 CUTE-LITE I LIGHT CURE UNIT
    K980793 Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
    K960364 CU-200 LIGHT CURE UNIT
    K960351 Q-LUX LIGHT CURE UNIT
    K953628 PROPHY ANGLE
    K952423 CU-100RLC LIGHT CURE UNIT, DOCUMENT NO.A715676
    K942199 CU-100R LIGHT CURE UNIT, DOCUMENT NO. A715676
    K942198 CU-80 LIGHT CURE UNIT, DOCUMENT NO. A715676
    Search all 12 clearances from Rolence Enterprise Co. , Ltd. →