BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DISPENSER, MERCURY & TABLET/POWDER

    K Number: K771396 · Decision Aug 3, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    206
    Review Days
    6

    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
    DISPENSER, MERCURY & TABLET/POWDER
    K Number
    K771396
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.3080
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Johnson & Johnson Professionals, Inc.
    Date Received
    July 28, 1977
    Decision Date
    August 3, 1977
    Product Code
    EHE
    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
    EHE Dispenser, Mercury And/Or Alloy

    Similar 510(k) Clearances

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

    AMALGAM DISPENSER

    FDA 510(k)
    FDA Class 1 ·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. →