BEUDAMED
    FDA Registration Active 🇫🇷 France

    MicroMega One Glider

    Reg #: 8030962 · FEI: 5615 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Micro-Mega SA
    Registration Number
    8030962
    FEI Number
    5615
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12 RUE DU TUNNEL
    City
    BESANCON Doubs
    Country
    FR

    Owner / Operator

    Firm Name
    Coltene/Whaledent AG
    Operator Number
    9089944
    Address
    Altstaetten, Feldwiesenstrasse 20
    City
    Altstaetten
    State
    Sankt Gallen
    Postal Code
    CH 9450
    Country
    CH

    US Agent

    Business Name
    Coltene/Whaledent Inc
    Contact Name
    Tricia Cregger
    Address
    235 ascot parkway
    City
    Cuyahoga Falls
    State
    OH
    ZIP
    44223
    Country
    US
    Email
    [email protected]
    Phone
    330 9168904

    Products

    Device Name Product Code
    File, Pulp Canal, Endodontic EKS

    Proprietary Names

    MicroMega One Glider R-ENDO HEDSTROEM FILES K FILES 2Shape Procedure Pack HyFlex™ CM 2Shape REMOVER ONE-G ONE CURVE STARTER PACK HERO SHAPER One curve ONE FLARE HERO 642 ONE CURVE PROCEDURE PACK H-Files K-Files K FILES Prime Line MicroMega REMOVER HYFLEX REMOVER MME Files MMC FILES HEDSTROEM FILES Prime Line 2 Shape Mini MicroMega One Curve Mini Procedure Pack MicroMega One Curve Mini MicroMega One Reci MicroMega One Reci Procedure Pack MicroMega Reci Glider 2 Shape Mini Procedure Pack

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)