BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Celara Extended-Pour Alginate

    Reg #: 3009432160 · FEI: 3009432160 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    anax USA
    Registration Number
    3009432160
    FEI Number
    3009432160
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    406 I ST NW ARDMORE
    City
    Ardmore
    State
    OK
    ZIP
    73401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K981091

    Owner / Operator

    Firm Name
    anaxdent North America
    Operator Number
    10039879
    Address
    406 I ST NW
    City
    Ardmore
    State
    OK
    Postal Code
    73401
    Country
    US
    Correspondent
    Tay Harvey

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    Celara Extended-Pour Alginate

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198