Data / Medical devices / France / Micro-Mega SA
Micro-Mega SA: FDA-registered device maker in BESANCON Doubs, France, 2 510(k) clearances
Micro-Mega SA is registered with the FDA (registration 8030962) in BESANCON Doubs, France. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 10, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8030962
- FEI number
- 5615
- Address
- 12 Rue Du Tunnel, BESANCON Doubs, France, 25000
- Owner or operator
- Coltene/Whaledent AG (9089944)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 22, 2010
- Registered through
- 2026
- Brand names listed
- 2 Shape Mini, 2 Shape Mini Procedure Pack, 2Shape, 2Shape Procedure Pack, CanalPro EDTA, CanalPro X-Move, H-Files, HEDSTROEM FILES and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Broach, Endodontic | EKW | 1 | Manufacturer | accessdata.fda.gov |
| Epilator, High Frequency, Needle-Type | KCW | 1 | Contract manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Exporter to the US | accessdata.fda.gov |
| Preparer, Root Canal Endodontic | EKQ | 1 | Exporter to the US | accessdata.fda.gov |
| Reamer, Pulp Canal, Endodontic | EKP | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 10, 2021 | K203320 | Endo Motor | EKX | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 24, 2004 | K042769 | ADSEAL ROOT CANAL SEALER | KIF | Substantially Equivalent | Meta Biomed Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Root Canal Filling
- All makers of File, Pulp Canal, Endodontic
- All makers of Broach, Endodontic
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Preparer, Root Canal Endodontic
- All makers of Reamer, Pulp Canal, Endodontic
Updated May 10, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.