BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Amann Girrbach AG

    Reg #: 3030515618 · FEI: 3030515618 · Expires 2026
    View on FDA
    Products
    20
    Proprietary Names
    45
    Establishment Types
    4
    Classifications
    20

    Registration Details

    Registration Name
    Amann Girrbach AG
    Registration Number
    3030515618
    FEI Number
    3030515618
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Gewerbestrasse 10
    City
    Maeder Vorarlberg
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K152383

    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

    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
    Powder, Porcelain EIH
    Device, Jaw Tracking, For Monitoring Jaw Positions NFS
    Teeth, Artificial, Backing And Facing ELK
    Point, Abrasive EHL
    Accessories, Implant, Dental, Endosseous NDP
    Facebow KCR
    Material, Impression Tray, Resin EBH
    Crown And Bridge, Temporary, Resin EBG
    Material, Tooth Shade, Resin EBF
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Teeth, Artificial, Posterior With Metal Insert ELJ
    Instrument, Diamond, Dental DZP
    Maintainer, Space Preformed, Orthodontic DYT
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Mouthguard, Prescription MQC
    Wheel, Polishing Agent EJQ
    Articulators EJP
    Plate, Base, Shellac EEA
    Alloy, Metal, Base EJH
    Crown And Bridge, Long-Term Temporary, Resin POW

    Proprietary Names

    Ceramill Zolid fx ML Ceramill Liquid fx Ceramill Zolid fx 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 NextDent Ortho Flex Ceramill HT+ white Zolid gen-x Zolid DRS Ceramill HT+ PS Zolid Bion 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 A-Splint Artex CR Limited Edition Gold Artex CP Artex CR Artex CT Artex BN Artex CPR Artex CN Ceramill Sintron Ceramill A-Temp Ceramill A-Temp ML Ceramill ZI CAM Ceramill ZI Ceramill Liquid new formula Ceramill Liquid

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198