BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇳 India

    Reverse Pull Adjustable Facemask

    K Number: K162543 · Decision Aug 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    350

    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
    Reverse Pull Adjustable Facemask
    K Number
    K162543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5500
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sawbros Industries Pvt., Ltd.
    Date Received
    September 12, 2016
    Decision Date
    August 28, 2017
    Product Code
    DZB
    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
    DZB Headgear, Extraoral, Orthodontic

    Similar 510(k) Clearances

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

    Orthodontic Facemask

    FDA 510(k)
    FDA Class 2 ·Dental

    PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF

    FDA 510(k)
    FDA Class 2 ·Dental

    KJ MASK

    FDA 510(k)
    FDA Class 2 ·Dental

    NITOM LOCKING FACEBOW

    FDA 510(k)
    FDA Class 2 ·Dental

    EQUA-PULL SAFETY RELEASE MODULE

    FDA 510(k)
    FDA Class 2 ·Dental

    KELES FACEMASK

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