BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    Thermoforming Nightguard/Mouthguard/Bleaching Tray

    Reg #: 3001295407 · FEI: 3001295407 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LABORATORIOS DENTALES DE ZONA FRANCA, S.A.
    Registration Number
    3001295407
    FEI Number
    3001295407
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ENTRADA A HIGUITO, SAN ISIDRO DEL GUARCO
    City
    CARTAGO
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K200125

    Owner / Operator

    Firm Name
    LABORATORIOS DENTALES DE ZONA FRANCA, S.A
    Operator Number
    9012389
    Address
    ENTRADA A HIGUITO, SAN ISIDRO DEL GUARCO
    City
    CARTAGO
    State
    CR-C
    Postal Code
    30802
    Country
    CR
    Correspondent
    Michelle - Gallup

    Products

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

    Proprietary Names

    Thermoforming Nightguard/Mouthguard/Bleaching Tray

    Establishment Types

    Manufacture Medical Device