Medical device licence · 99101 · Class 2
ROTARY ENDODONTIC INSTRUMENTS (NITINOL)
Yes: licensed in Canada
Licence status Issued (active); first licensed May 8, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99101
- Licence holder
- Fkg Dentaire SarlLe Cret-Du-Locle, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 8, 2017
- Devices covered
- 40
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIORACE
- BT-RACE
- EDGE X7 UTOPIA
- EDGEDIAMOND UTOPIA
- EDGEFILE X3
- EDGEFILE X3 ASSORTMENT
- EDGEFILE X7
- EDGEFILE X7 ASSORTMENT
- EDGEGLIDEPATH
- EDGEONE FIRE
- EDGEONE FIRE ASSORTMENT
- EDGEONE GLIDEPATH
- EDGESEQUEL SAPPHIRE
- EDGESEQUEL SAPPHIRE ASSORTMENT
- EDGESEQUEL UTOPIA
- EDGETAPER
- EDGETAPER ASSORTMENT
- EDGETAPER PLATINUM
- EDGETAPER PLATINUM ASSORTMENT
- FKG-CMT
- FKG-OPENER
- FKG-SWL
- PRERACE
- R-MOTION
- RACE
- RONDO EPOFLEX
- SCOUTRACE
- XP-4D ASSORTMENT
- XP-4D LARGE
- XP-4D MEDIUM
- XP-4D SEQUENCE
- XP-4D STANDARD
- XP-4D STARTER
- XP-ENDO FINISHER
- XP-ENDO FINISHER R
- XP-ENDO RISE GLIDER
- XP-ENDO RISE RETREATMENT
- XP-ENDO RISE SEQUENCE
- XP-ENDO RISE SHAPER
- XP-ENDO SHAPER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.