BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    Straumann Jason Membrane

    K Number: K173562 · Decision Jul 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    56
    Applicant Total
    90
    Review Days
    234

    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
    Straumann Jason Membrane
    K Number
    K173562
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Institut Straumann AG
    Date Received
    November 17, 2017
    Decision Date
    July 9, 2018
    Product Code
    NPL
    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
    NPL Barrier, Animal Source, Intraoral

    Similar 510(k) Clearances

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

    Jason membrane

    FDA 510(k)
    FDA Class 2 ·Dental

    Augmented Gingival Matrix

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack

    FDA 510(k)
    FDA Class 2 ·Dental

    SwissMembrane X; SwissMembrane X Socket

    FDA 510(k)
    FDA Class 2 ·Dental

    Soft Tissue Augmentation Resorbable Matrix

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

    Other Clearances by Institut Straumann AG

    K Number Device Name
    K260726 Straumann® ProClean™ Cassette (041.800 ; 041.801)
    K260460 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
    K252168 Straumann® BLC Implants - Indication Widening
    K253315 Straumann Variobase Abutments XC for Bridge/Bar
    K250294 Straumann® RidgeFit Implants
    K243278 Custom Abutments
    K243478 Straumann InLab Validated Workflow
    K233252 Straumann CARES Visual and Nova Dental CAD
    K241391 Straumann® PURE Ceramic Implants
    K234049 Straumann® BLC and TLC Implants - Line extension
    Search all 90 clearances from Institut Straumann AG →