BEUDAMED
    FDA Registration Active 🇫🇷 France

    Micro-Mega SA

    Reg #: 8030962 · FEI: 5615 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    41
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    Micro-Mega SA
    Registration Number
    8030962
    FEI Number
    5615
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12 RUE DU TUNNEL
    City
    BESANCON Doubs
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K203320

    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
    Preparer, Root Canal Endodontic EKQ
    Reamer, Pulp Canal, Endodontic EKP
    Epilator, High Frequency, Needle-Type KCW
    File, Pulp Canal, Endodontic EKS
    Handpiece, Direct Drive, Ac-Powered EKX
    Broach, Endodontic EKW
    Resin, Root Canal Filling KIF

    Proprietary Names

    CanalPro EDTA MM-EDTA CREAM K REAMERS K REAMERS Prime Line K-Reamers STERILE DISPOSABLE NEEDLE (L,K,F,.......) One curve 2Shape R-ENDO ONE CURVE STARTER PACK ONE-G HERO SHAPER MicroMega REMOVER HERO 642 2Shape Procedure Pack HyFlex™ CM HEDSTROEM FILES K FILES H-Files ONE FLARE HYFLEX REMOVER ONE CURVE PROCEDURE PACK MME Files HEDSTROEM FILES Prime Line K FILES Prime Line REMOVER MMC FILES K-Files MicroMega One Reci Procedure Pack 2 Shape Mini MicroMega One Curve Mini 2 Shape Mini Procedure Pack MicroMega One Curve Mini Procedure Pack MicroMega One Reci MM K-Files, MM H-Files, MM K-Reamers MicroMega Reci Glider MM TAPER MicroMega One Glider CanalPro X-Move NERVE BROACHES MM-SEAL

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)