BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Amann Girrbach North America, LP

    Reg #: 3005942449 · FEI: 3005942449 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    44
    Establishment Types
    1
    Classifications
    9

    Registration Details

    Registration Name
    Amann Girrbach North America, LP
    Registration Number
    3005942449
    FEI Number
    3005942449
    Status
    Active
    Expiry Year
    2026
    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
    Powder, Porcelain EIH
    Crown And Bridge, Long-Term Temporary, Resin POW
    Crown And Bridge, Temporary, Resin EBG
    Alloy, Metal, Base EJH
    Facebow KCR
    Articulators EJP
    Device, Jaw Tracking, For Monitoring Jaw Positions NFS
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    Ceramill A-Splint Ceramill HT+ white Zolid gen-x Zolid DRS Ceramill HT+ PS Zolid Bion Ceramill ZI CAM Ceramill ZI Ceramill Liquid new formula Ceramill Liquid Ceramill A-Temp Ceramill A-Temp ML Ceramill Sintron Clinometer Porus buttons long Bite fork total Bite fork partial Artex Quickbite Leipzig Nasion Joint support Tray handle Artex facebow Nasion vertically adjustable Axis plane pointer with screw Artex CR Limited Edition Gold Artex CP Artex CR Artex CT Artex BN Artex CPR Artex CN 179130 Ceramill Map 200 179140-IDC IDC S1 179140 Ceramill Map 400 179130-IDC IDC S2 179560-IDC IDC S3 179560 Ceramill Map 600 179130NC Ceramill Map 200+ 179140NC Ceramill Map 400+ 179560N Ceramill Map600+ 179570 Ceramill Map FX Ceramill Zolid fx ML Ceramill Liquid fx Ceramill Zolid fx

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198