BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ceramill A-Splint

    Reg #: 3005942449 · FEI: 3005942449 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Amann Girrbach North America, LP
    Registration Number
    3005942449
    FEI Number
    3005942449
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    13900 South Lakes Drive, Suite D
    City
    Charlotte
    State
    NC
    ZIP
    28273
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191836

    Owner / Operator

    Firm Name
    Amann Girrbach AG
    Operator Number
    9093103
    Address
    Amann Girrbach AG, Gewerbestrasse 10
    City
    Maeder
    State
    Vorarlberg
    Postal Code
    6841
    Country
    AT
    Correspondent
    Debora Engel

    Products

    Device Name Product Code
    Mouthguard, Prescription MQC

    Proprietary Names

    Ceramill A-Splint

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198