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

    DENTAL ELECTRONIC/S.B.R TRADING BU HAND

    K Number: K831824 · Decision Aug 11, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    17
    Applicant Total
    2
    Review Days
    65

    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
    DENTAL ELECTRONIC/S.B.R TRADING BU HAND
    K Number
    K831824
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4620
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Silverman'S
    Date Received
    June 7, 1983
    Decision Date
    August 11, 1983
    Product Code
    EAY
    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
    EAY Light, Fiber Optic, Dental

    Similar 510(k) Clearances

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

    MODEL A15-101

    FDA 510(k)
    FDA Class 1 ·Dental

    MODEL A15-103

    FDA 510(k)
    FDA Class 1 ·Dental

    JEDENTAL VLC DENTAL CURING LIGHT

    FDA 510(k)
    FDA Class 1 ·Dental

    STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM

    FDA 510(k)
    FDA Class 1 ·Dental

    POWER OPTIC

    FDA 510(k)
    FDA Class 1 ·Dental

    DENTISCOPE

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

    Other Clearances by Silverman'S

    K Number Device Name
    K801975 LITTLE GIANT I & II HANDPIECE CONTROL