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

    CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)

    K Number: K962733 · Decision Oct 11, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    144
    Registration Numbers
    144
    Same Product Code
    504
    Applicant Total
    14
    Review Days
    88

    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
    CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)
    K Number
    K962733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3275
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Union Broach, Div. Moyco Industries, Inc.
    Date Received
    July 15, 1996
    Decision Date
    October 11, 1996
    Product Code
    EMA
    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
    EMA Cement, Dental

    Similar 510(k) Clearances

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

    G-CEM UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Dental

    REGEN Bioactive Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    Bifix Veneer LC, Bifix Veneer Try-In

    FDA 510(k)
    FDA Class 2 ·Dental

    iCEM Universal Plus

    FDA 510(k)
    FDA Class 2 ·Dental

    TopCEM Vigor SA Self-Adhesive Resin Cement

    FDA 510(k)
    FDA Class 2 ·Dental

    GlasIonomer FX-LC

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

    Other Clearances by Union Broach, Div. Moyco Industries, Inc.

    K Number Device Name
    K950365 MOYCO-EDTA
    K941574 RETRO MIRROR
    K940260 THERMAL PULP TESTER
    K935542 NICKEL-TITANIUM K-TYPE FILE
    K931742 INJECT-R FILL
    K923661 QUADRASORB FILTER
    K895174 UNION BROACH BLEACHING LIGHT
    K855136 FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE
    K852474 UNION BROACH BLEACHING LIGHT
    K823489 ENDODONTIC BROACH-BARBED BROACH
    Search all 14 clearances from Union Broach, Div. Moyco Industries, Inc. →