Maillefer Instruments Holding Sàrl
CH-MF-000016301 · Switzerland · BALLAIGUES
Maillefer Instruments Holding Sàrl is registered in the European database on medical devices as a manufacturer, with 288 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 288 |
|---|
Most frequent device types declared: RECIPROC® Minima, WaveOne Gold (SU, NiTi, Ro, MSA).
Among these devices, 231 are declared sterile, 52 implantable.
Authorised representative in the Union: Dentsply DeTrey GmbH.
Devices declared under this manufacturer
- ANTÆOS® Conventional Gutta-Percha
- Alpha Gutta-Percha
- FlexMaster®
- Gutta Core® for WaveOne® Gold Size Verifiers
- MTwo® Gutta-Percha
- Mtwo®
- R-PILOT®
- RECIPROC®
- RECIPROC® Minima
- RECIPROC® blue
- Reciproc® Gutta-Percha
- Triniti® Rotary NiTi Files
Showing 12 of 288 declared devices.
Catalogue references include MSTRCPM625035, MSTRMPPM00025, MSTVROT421430, MSTVROT431520, MSTVROT625460, V040234025050.
European nomenclature codes declared: L159004, Q010507, Q01010203, Q01010401.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | MAILLEFER INSTRUMENTS HOLDING SARL (CH) · FDA 8031010 |
| Devices in EUDAMED | 288 |
| Country of registration | Switzerland |
⚠️ A similar name exists; we do not assert it is the same company — why.
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | MAILLEFER INSTRUMENTS HOLDING SARL |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 3 |
| Class 3 devices | 8 |
| First licensed | 1999-08-25 |
Licence types: Device Family (10), Device Group Family (1).
Licensed under: DENSFIL PLASTIC OBTURATORS, GUTTA PERCHA POINTS (DENTSPLY CAULK), PLASTIC ENDODONTIC OBTURATORS, GUTTA PERCHA POINTS, GUTTA PERCHA, DENSFIL TITANIUM ENDODONTIC OBTURATORS.