BEUDAMED
    FDA Registration Active 🇺🇸 United States

    G21 Flex Beads

    Reg #: 3016592693 · FEI: 3016592693 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DIMENSIONAL BIOCERAMICS, LLC
    Registration Number
    3016592693
    FEI Number
    3016592693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2161 Delaware Avenue, Suite A
    City
    Santa Cruz
    State
    CA
    ZIP
    95060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171161

    Owner / Operator

    Firm Name
    DImensional Bioceramics
    Operator Number
    10062613
    Address
    306 Turnberry Ct
    City
    Lebanon
    State
    IN
    Postal Code
    46052
    Country
    US
    Correspondent
    Patsy J Trisler

    Products

    Device Name Product Code
    Filler, Bone Void, Calcium Compound MQV

    Proprietary Names

    G21 Flex Beads Arthrex® Calcium Sulfate BioBeads InterSep

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility