BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    Glass Ionomer Luting Cement Radiopa

    Reg #: 8044038 · FEI: 3001027751 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ADVANCED HEALTHCARE LTD.
    Registration Number
    8044038
    FEI Number
    3001027751
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    UNITS 2-4, LEAVERS ESTATE, CHIDDINGSTONE CAUSEWAY
    City
    TONBRIDGE Kent
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K982461

    Owner / Operator

    Firm Name
    ADVANCED HEALTHCARE LTD.
    Operator Number
    9005225
    Address
    UNITS 2-4, LEAVERS ESTATE, CHIDDINGSTONE CAUSEWAY
    City
    TONBRIDGE
    State
    Kent
    Postal Code
    TN11 8JU
    Country
    GB
    Correspondent
    Jeremy J Clarke

    US Agent

    Business Name
    REGISTRAR CORP
    Contact Name
    DAVID LENNARZ
    Address
    144 Research Dr
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Cement, Dental EMA

    Proprietary Names

    Glass Ionomer Luting Cement Radiopa GlasIonomer Cement CX-Plus

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device