BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    FREEPRINT splintmaster taff 1000g

    Reg #: 9680954 · FEI: 1000293792 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DETAX GMBH
    Registration Number
    9680954
    FEI Number
    1000293792
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    CARL-ZEISS-STR. 4
    City
    ETTLINGEN Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K232448

    Owner / Operator

    Firm Name
    DETAX GMBH
    Operator Number
    9012556
    Address
    CARL-ZEISS-STR. 4, --
    City
    ETTLINGEN
    State
    Baden-Wurttemberg
    Postal Code
    76275
    Country
    DE

    US Agent

    Business Name
    Aclivi, LLC
    Contact Name
    Chris Brown
    Address
    3250 Brackley Dr
    City
    Ann Arbor
    State
    MI
    ZIP
    48105
    Country
    US
    Email
    [email protected]
    Phone
    810 3609773

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC
    Positioner, Tooth, Preformed KMY

    Proprietary Names

    FREEPRINT splintmaster taff 1000g Primeprint Splint ST 1000g FREEPRINT splintmaster flex 1000g Primeprint Splint SF 1000g

    Establishment Types

    Manufacture Medical Device