BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MicroMega One Glider

    Reg #: 2416455 · FEI: 2416455 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COLTENE/WHALEDENT INC.
    Registration Number
    2416455
    FEI Number
    2416455
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    235 Ascot Pkwy
    City
    CUYAHOGA FALLS
    State
    OH
    ZIP
    44223
    Country
    US

    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

    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