FKG Dentaire Sàrl
CH-MF-000017925 · Switzerland · Le Crêt-du-Locle
FKG Dentaire Sàrl is registered in the European database on medical devices as a manufacturer, with 1 168 devices declared. It has a similarly named entry in the FDA register that we have not verified.
What this manufacturer declares
| Class IIa | 1 168 |
|---|
Most frequent device types declared: 01.554.31.010.CG, 01.7B0.00.0EO.FK, 02.110.21.015.CG, 03.050.31.025.CT, 03.140.10.605.GC.
Among these devices, 565 are declared sterile, 673 reusable.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- BIORACE
- Calcinable Pins
- EDGE SEQUEL SAPPHIRE
- EDGEFILE X3
- EDGEFILE X7
- EDGEONE FIRE
- EDGETAPER
- ENDOWAVE
- K-FILES FLEX
- PLUGGERS
- R-Motion
- RACE
Showing 12 of 1 168 declared devices.
Catalogue references include 01.7B0.00.0AZ.FK, 05.300.00.101.TR, 6825-435, 99.X00.80.S03.FK, ES150625HTS, ES250425HTS.
European nomenclature codes declared: L159004, Q010507, Q010199, Q01010401, L159012.
United States market access
| FDA establishment register | Similar name found — unverified |
|---|---|
| Matched entry | FKG DENTAIRE SARL (CH) · FDA 9680913 |
| Devices in EUDAMED | 1 168 |
| Country of registration | Switzerland |
⚠️ A similar name exists; we do not assert it is the same company — why.
Device-level evidence
| Devices with a numeric GTIN | 1 168 |
|---|---|
| Found in the U.S. device database | 392 |
| Share | 33.6 % |
Canadian market access
| Health Canada licence listing | Similar name found — unverified |
|---|---|
| Matched entry | FKG DENTAIRE SARL |
⚠️ A similar name exists; unverified — why.
What it holds in Canada
| Licences on record | 4 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 4 |
| First licensed | 2017-05-08 |
Licence types: Device Family (4).
Licensed under: ROTARY ENDODONTIC INSTRUMENTS (NITINOL), PASTE FILLERS, BARBED BROACHES, ENLARGERS.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
CH24/00000083 | supplemented | 2029-09-27 |