BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    BIODENTA SWISS AG

    Reg #: 3008088588 · FEI: 3008088588 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BIODENTA SWISS AG
    Registration Number
    3008088588
    FEI Number
    3008088588
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Tramstrasse 16
    City
    Berneck Sankt Gallen
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K123512

    Owner / Operator

    Firm Name
    Biodenta Swiss AG
    Operator Number
    10030896
    Address
    Tramstrasse 16
    City
    Berneck
    State
    Sankt Gallen
    Postal Code
    9442
    Country
    CH

    US Agent

    Business Name
    Dynamic Biotech, Inc.
    Contact Name
    Feng-Yu Lee
    Address
    29122 Rancho Viejo Rd., Suite 212
    City
    San Juan Capistrano
    State
    CA
    ZIP
    92675
    Country
    US
    Email
    [email protected]
    Phone
    949 2180929

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Biodenta Dental Implant System - Bone Level D 3 to 6 mm Implant, Endosseous, Root-Form - Biodenta Dental Implant System - Bone Level Tapered D 3 and L 6.5 mm Biodenta Customized Abutment - Hybrid Biodenta Dental Implant System (Bone Level) Biodenta Dental Implant System - Abutments Biodenta Dental Implant System - Multi-Use Abutment Biodenta Customized Abutment - Titanium Biodenta Dental Implant System (Bone Level Tapered) Biodenta Dental Implant System Biodenta Dental Implant System - Surgical and Prosthetic Accessory Biodenta / DentaSwiss Scanbody

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility