BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ISPA 3.5x16 Implant Superior Active 0 3.5 L 16

    Reg #: 3015383403 · FEI: 3015383403 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ALPHA DENT IMPLANTS GMBH
    Registration Number
    3015383403
    FEI Number
    3015383403
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Hanauer strasse 8
    City
    Pforzheim Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K180968

    Owner / Operator

    Firm Name
    Alpha Dent Implants GmbH
    Operator Number
    10086730
    Address
    Hanauer strasse 8
    City
    Pforzheim
    State
    DE-NOTA
    Postal Code
    75181
    Country
    DE

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    ISPA 3.5x16 Implant Superior Active 0 3.5 L 16 ISPA 6x13 Implant Superior Active 0 6 L 13 ISPA 5.5x8 Implant Superior Active 0 5.5 L 8 IAB +4.2x10 Implant Active Bio Plus 0 4.2 L 10 ISPA 6x11.5 Implant Superior Active 0 6 L 11.5 IAB +3.75x13 Implant Active Bio Plus 0 3.75 L 13 IAB +3.75x8 Implant Active Bio Plus 0 3.75 L 8 ISPA 5x16 Implant Superior Active 0 5 L 16 ISPA 3.5x13 Implant Superior Active 0 3.5 L 11.5 IAB +3.75x11.5 Implant Active Bio Plus 0 3.75 L 11.5 ISPA 6x10 Implant Superior Active 0 6 L 10 ISPA 5x13 Implant Superior Active 0 5 L 13 IAB +3.3x10 Implant Active Bio Plus 0 3.3 L 10 ISPA 5.5x13 Implant Superior Active 0 5.5 L 13 ISPA 4.5x16 Implant Superior Active 0 4.5 L 16 IAB +3.75x16 Implant Active Bio Plus 0 3.75 L 16 ISPA 6x8 Implant Superior Active 0 6 L 8 IAB +5x8 Implant Active Bio Plus 0 5 L 8 ISPA 4.5x13 Implant Superior Active 0 4.5 L 13 ISPA 5x11.5 Implant Superior Active 0 5 L 11.5 Dental implant "Zahntium Implant" ISPA 4.5x10 Implant Superior Active 0 4.5 L 10 IAB +3.75x10 Implant Active Bio Plus 0 3.75 L 10 ISPA 3.5x8 Implant Superior Active 0 3.5 L 8 IAB +4.2x16 Implant Active Bio Plus 0 4.2 L 16 IAB +3.3x11.5 Implant Active Bio Plus 0 3.3 L 11.5 ISPA 3.5x10 Implant Superior Active 0 3.5 L 10 IAB +3.3x8 Implant Active Bio Plus 0 3.3 L 8 ISPA 4.5x8 Implant Superior Active 0 4.5 L 8 IAB +5x10 Implant Active Bio Plus 0 5 L 10 ISPA 4x8 Implant Superior Active 0 4 L 8 ISPA 4x16 Implant Superior Active 0 3.5 L 16 IAB +4.2x8 Implant Active Bio Plus 0 4.2 L 8 ISPA 4.5x11.5 Implant Superior Active 0 4.5 L 11.5 IAB +6x11.5 Implant Active Bio Plus 0 6 L 11.5 IAB +6x8 Implant Active Bio Plus 0 6 L 8 ISPA 4x13 Implant Superior Active 0 4 L 13 IAB +6x13 Implant Active Bio Plus 0 6 L 13 ISPA 4x11.5 Implant Superior Active 0 4 L 11.5 ISPA 5.5x11.5 Implant Superior Active 0 5.5 L 11.5 Prosthetic Components Zahntium IAB 5x11.5 Implant Active Bio Plus 0 5 L 11.5 ISPA 5.5x10 Implant Superior Active 0 5.5 L 10 Zahntium IAB +3.3x13 Implant Active Bio Plus 0 3.3 L 13 IAB +4.2x11.5 Implant Active Bio Plus 0 4.2 L 11.5 ISPA 4x10 Implant Superior Active 0 4 L 10 IAB+ 5x13 Implant Active Bio Plus 0 5 L 13 IAB +4.2x13 Implant Active Bio Plus 0 4.2 L 13 ISPA 5x10 Implant Superior Active 0 5 L 10 ISPA 5x8 Implant Superior Active 0 5 L 8

    Establishment Types

    Manufacture Medical Device