BEUDAMED
    FDA Registration Active 🇨🇭 Switzerland

    Fiber-Splint Lab Bridge

    Reg #: 8031054 · FEI: 1000558210 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    POLYDENTIA S.A.
    Registration Number
    8031054
    FEI Number
    1000558210
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    VIA CANTONALE 47
    City
    MEZZOVICO-Vira Ticino
    Country
    CH

    Regulatory Submissions

    510(k) Number
    K962374

    Owner / Operator

    Firm Name
    Polydentia S.A.
    Operator Number
    9076845
    Address
    Via Cantonale 47
    City
    Mezzovico- Vira
    State
    Ticino
    Postal Code
    CH-6805
    Country
    CH

    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
    Resin, Denture, Relining, Repairing, Rebasing EBI

    Proprietary Names

    Fiber-Splint Lab Bridge Fiber-Bond Fiber-Splint Lab Ret Fiber-Splint ML Mini Starter Kit Fiber-Plast Fiber-Splint Fiber-Splint Lab- System Fiber-Splint ML Multy-Layer Fiber-Splint Ortho Fiber-Splint Ortho Evolution F-Splint-Aid F-Splint-Aid Slim

    Establishment Types

    Manufacture Medical Device