BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DEFEND Ear-loop Face Masks

    K Number: K201127 · Decision Apr 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    16
    Review Days
    351

    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
    DEFEND Ear-loop Face Masks
    K Number
    K201127
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Young Dental Manufacturing Co. 1, LLC
    Date Received
    April 28, 2020
    Decision Date
    April 14, 2021
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FXX Mask, Surgical

    Similar 510(k) Clearances

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

    HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround Visor

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Surgical Face Mask (Ear mount)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Disposable Surgical Face Mask (3P00B, C2900)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Disposable Medical Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KP Protective Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Young Dental Manufacturing Co. 1, LLC

    K Number Device Name
    K241041 Silver Fluoride Hypersensitivity Varnish
    K171377 Young INFINITY Cordless Handpiece System
    K153334 Oral-B 5% Sodium Fluoride Varnish
    K932255 YOUNG D'GRANULATOR
    K903284 YOUNG PROPHY SYSTEM, PS UNIT
    K875340 JETPOLISHER(TM)
    K875339 JETPOLISHER AIRPOLISHING POWDER
    K821484 DAWN LOW SPEED HANDPIECE SYSTEM
    K790723 PROPHYLAXIS CUPS AND POLISHERS
    K790722 PROPHYLAXIS ANGLE
    Search all 16 clearances from Young Dental Manufacturing Co. 1, LLC →