BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Prosthetic Components Sigma Implants

    Reg #: 3015383403 · FEI: 3015383403 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    82
    Establishment Types
    1
    Classifications
    2

    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
    K210499

    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
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    Prosthetic Components Sigma Implants Wide.Healing CAP 0 8.L-4.5 IAB +6x13 Implant Active Bio Plus 0 6 L 13 Implant Active Bio Plus 0 Implant Active Bio Plus Wide.Healing CAP 0 8.L-3.5 IAB +3.75x16 Implant Active Bio Plus 0 3.75 L 16 IAB +4.2x16 Implant Active Bio Plus 0 4.2 L 16 IAB +3.3x8 Implant Active Bio Plus 0 3.3 L 8 ISPA 4.5x11.5 Implant Superior Active 0 4.5 L 11.5 Implant Superior Active 0 5.5 L 8 ISPA 5x13 Implant Superior Active 0 5 L 13 HCWK 8/3 Wide Healing CAP 0 8 L 3.5 IAB +6x11.5 Implant Active Bio Plus 0 6 L 11.5 IAB +4.2x10 Implant Active Bio Plus 0 4.2 L 10 ISPA 3.5x8 Implant Superior Active 0 3.5 L 8 ISPA 5.5x11.5 Implant Superior Active 0 5.5 L 11.5 ISPA 5.5x13 Implant Superior Active 0 5.5 L 13 HCWK 6.5/3 Wide Healing CAP 0 6.5 L 3.5 Wide Healing CAP 0 6.5 L 4.5 IAB +4.2x13 Implant Active Bio Plus 0 4.2 L 13 IAB +3.75x13 Implant Active Bio Plus 0 3.75 L 13 ISPA 3.5x16 Implant Superior Active 0 3.5 L 16 HCAEK Healing Cap for Aesthetic Abutment Konus Wide Healing CAP 0 5.5 L 7.5 IAB +4.2x8 Implant Active Bio Plus 0 4.2 L 8 ISPA 4x16 Implant Superior Active 0 4 L 16 Wide.Healing CAP 0 6.5.L-5.5 IAB +3.75x10 Implant Active Bio Plus 0 3.75 L 10 ISPA 5x8 Implant Superior Active 0 5 L 8 IAB +3.3x13 Implant Active Bio Plus 0 3.3 L 13 ISPA 4x10 Implant Superior Active 0 4 L 10 IAB +3.3x10 Implant Active Bio Plus 0 3.3 L 10 4.5 L 13 Implant Superior Active 0 4.5 L 13 ISPA 5x11.5 Implant Superior Active 0 5 L 11.5 TAK 3/004 Titanium Abutment Konus 3 4 mm Wide.Healing CAP 0 6.5.L-7 IAB+ 5x13 Implant Active Bio Plus 0 5 L 13 ISPA 5x10 Implant Superior Active 0 5 L 10 HCWK 3/7 Wide Healing CAP 0 5.5 L 7.5 mplant Active, Active Plus Implants, Implant Active +, Implant Classic, INTEGRAL Implants, IAB +6x8 Implant Active Bio Plus 0 6 L 8 HCAEM Healing Cap wide for Angular Multi-Unit 17°/30° IAB +5x8 Implant Active Bio Plus 0 5 L 8 IAB +4.2x11.5 Implant Active Bio Plus 0 4.2 L 11.5 ISPA 4x13 Implant Superior Active 0 4 L 13 ISPA 3.5x11.5 Implant Superior Active 0 3.5 L 11.5 ISPA 4.5x16 Implant Superior Active 0 4.5 L 16 ISPA 3.5x10 Implant Superior Active 0 3.5 L 10 HCAEM- W Healing Cap wide for Angular Multi-Unit 17°/30° HCAEM Healing Cap for Angular Multi-Unit 17°/30° ISPA 4x8 Implant Superior Active 0 4 L 8 Titanium Abutment Konus 3 4 mm ISPA 6x10 IAB +6x10 Implant Active Bio Plus 0 6 L 10 ISPA 4.5x8 Implant Superior Active 0 4.5 L 8 IAB +5x10 Implant Active Bio Plus 0 5 L 10 IAB +3.75x11.5 Implant Active Bio Plus 0 3.75 L 11.5 Implant Superior Active 0 6 L 10 Wide Healing CAP 0 6.5 L 3.5 Wide Healing CAP 0 8 L 3.5 Implant Active Konus, Implant Classic Konus, Implant Active Bio, PROSTHETIC COMPONENTS ISPA 4x11.5 Implant Superior Active 0 4 L 11.5 ISPA 5.5x10 Implant Superior Active 0 5.5 L 10 ISPA 6x8 Implant Superior Active 0 6 L 8 ISPA 6x13 Implant Superior Active 0 6 L 13 HCWK 6.5/5 Wide Healing CAP 0 6.5 L 4.5 dental Implant " Implant Classic_" TAK 3/004 Titanium Abutment Konus 3.4 mm IAB +3.3x11.5 Implant Active Bio Plus 0 3.3 L 11.5 ISPA 4.5x10 Implant Superior Active 0 4.5 L 10 HCWK 6.5/4 Wide Healing CAP 0 6.5 L 4.5 ISPA 5x16 Implant Superior Active 0 5 L 16 Wide Healing CAP 0 6.5 L 7 Wide Healing CAP 0 8 L 4.5 ISPA 6x11.5 Implant Superior Active 0 6 L 11.5 HCWK 8/4 Wide Healing CAP 0 8 L 4.5 IAB 5x11.5 Implant Active Bio Plus 0 5 L 11.5 ISPA 3.5x13 Implant Superior Active 0 3.5 L 13 Wide Healing CAP 0 6.5 L 5.5 HCWK 6.5/7 Wide Healing CAP 0 6.5 L 7 Sigma Implants Implant Active Bio Plus 0 3.75 L 8 dental implants "Implant Active Bio_"

    Establishment Types

    Manufacture Medical Device