BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇫🇷 France

    MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE

    K Number: K111532 · Decision Oct 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    72
    Applicant Total
    6
    Review Days
    126

    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
    MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE
    K Number
    K111532
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4200
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anthogyr Sas
    Date Received
    June 3, 2011
    Decision Date
    October 7, 2011
    Product Code
    EGS
    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
    EGS Handpiece, Contra- And Right-Angle Attachment, Dental

    Similar 510(k) Clearances

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

    Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

    FDA 510(k)
    FDA Class 1 ·Dental

    Disposable Prophy Angle

    FDA 510(k)
    FDA Class 1 ·Dental

    Star E900 Handpiece Series

    FDA 510(k)
    FDA Class 1 ·Dental

    General Cutting Straight

    FDA 510(k)
    FDA Class 1 ·Dental

    FX Contra

    FDA 510(k)
    FDA Class 1 ·Dental

    Smooth Drive contra angle and straight handpieces

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

    Other Clearances by Anthogyr Sas

    K Number Device Name
    K161177 Axiom PX
    K141450 AXIOM 2.8
    K131066 AXIOM REG
    K102241 ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT
    K101913 ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM