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

    J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT

    K Number: K850073 · Decision Feb 8, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    51
    Applicant Total
    206
    Review Days
    30

    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
    J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT
    K Number
    K850073
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3310
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    January 9, 1985
    Decision Date
    February 8, 1985
    Product Code
    EBD
    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
    EBD Coating, Filling Material, Resin

    Similar 510(k) Clearances

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

    GLOSSY COAT (15ML)

    FDA 510(k)
    FDA Class 2 ·Dental

    ID LIGHT CURE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    visio.lign color, visio.lign shield

    FDA 510(k)
    FDA Class 2 ·Dental

    RODIN Palette Naturalizing Kit

    FDA 510(k)
    FDA Class 2 ·Dental

    VITA Akzent LC

    FDA 510(k)
    FDA Class 2 ·Dental

    Nano Varnish, Plaquit, Lightpaint on Surface

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

    Other Clearances by Johnson & Johnson Professionals, Inc.

    K Number Device Name
    K992173 SIPHONGUARD CSF CONTROL DEVICE
    K991413 CODMAN ETHISORB DURA PATCH
    K991222 CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
    K982379 SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
    K982812 G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)
    K983141 CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
    K983014 SUMMIT ACETABULAR SYSTEM
    K980778 HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
    K974739 HAKIM PROGRAMMABLE VALVE SYSTEM
    K980801 J-FX BIPOLAR HEAD
    Search all 206 clearances from Johnson & Johnson Professionals, Inc. →