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

    Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®

    K Number: K251786 · Decision Jul 11, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    39
    Applicant Total
    27
    Review Days
    30

    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
    Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®
    K Number
    K251786
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geistlich Pharma AG
    Date Received
    June 11, 2025
    Decision Date
    July 11, 2025
    Product Code
    NPM
    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
    NPM Bone Grafting Material, Animal Source

    Similar 510(k) Clearances

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

    BOSS

    FDA 510(k)
    FDA Class 2 ·Dental

    SwissGraft X

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Flow®

    FDA 510(k)
    FDA Class 2 ·Dental

    Xenograft Bovine Bone Particulate

    FDA 510(k)
    FDA Class 2 ·Dental

    THE Graft Collagen

    FDA 510(k)
    FDA Class 2 ·Dental

    Geistlich Bio-Oss®

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

    Other Clearances by Geistlich Pharma AG

    K Number Device Name
    K260364 Device 300419 Strip
    K260532 Derma-Gide
    K251323 Device 104 Particulate
    K252253 Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
    K251062 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
    K251556 Device 300423 Granules
    K251613 SwissGraft X
    K250833 SwissMembrane X; SwissMembrane X Socket
    K242510 Geistlich Bio-Flow®
    K241802 Device 300397 Putty
    Search all 27 clearances from Geistlich Pharma AG →