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

    MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY

    K Number: K833132 · Decision Feb 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    9
    Applicant Total
    8
    Review Days
    150

    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
    MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY
    K Number
    K833132
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6140
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Myo-Tronics Research, Inc.
    Date Received
    September 13, 1983
    Decision Date
    February 10, 1984
    Product Code
    EFH
    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
    EFH Paper, Articulation

    Similar 510(k) Clearances

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

    PFINGST PRESSURE PASTE

    FDA 510(k)
    FDA Class 1 ·Dental

    OCCLUDE

    FDA 510(k)
    FDA Class 1 ·Dental

    HYDENT

    FDA 510(k)
    FDA Class 1 ·Dental

    FIXTECTOR

    FDA 510(k)
    FDA Class 1 ·Dental

    REVISED T-SCAN SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    ARTICULATING PAPER

    FDA 510(k)
    FDA Class 1 ·Dental
    View all

    Other Clearances by Myo-Tronics Research, Inc.

    K Number Device Name
    K842223 J4 MYO-MONITOR
    K842224 BNS 40
    K831364 TESTCORP RA
    K830034 MODEL EM-2 BIOELECTRIC PROCESSOR
    K813533 ELECTRIC MUSCLE STIMULATOR
    K810528 MODEL EM-IR
    K770252 MONITOR, MYO, MODEL J3