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

    Cytoplast Titanium-Reinforced PTFE Membranes

    K Number: K201187 · Decision Jan 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    30
    Applicant Total
    8
    Review Days
    267

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    Basic Information

    Device Name
    Cytoplast Titanium-Reinforced PTFE Membranes
    K Number
    K201187
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteogenics Biomedical, Inc.
    Date Received
    May 1, 2020
    Decision Date
    January 23, 2021
    Product Code
    NPK
    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
    NPK Barrier, Synthetic, Intraoral

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    Other Clearances by Osteogenics Biomedical, Inc.

    K Number Device Name
    K171774 RPM Reinforced PTFE Mesh
    K093719 PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
    K072076 CYTOPLAST PTFE SUTURE
    K013764 IMMIX BONE GRAFT EXTENDER
    K003028 CYTOPLAST SUTURE; CS-0318, CS-0416, CS-0418, CS-0513, CS-0513PC, CS-0516HC
    K993610 CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250
    K984230 OSTEO-MESH TM-300