Medical device licence · 99386 · Class 2
ENDODONTIC PULP CANAL FILES
Yes: licensed in Canada
Licence status Issued (active); first licensed July 5, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99386
- Licence holder
- Peter Brasseler Holdings, LlcSavannah, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 5, 2017
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIORACE
- BT RACE
- ENDOSEQUENCE
- ENDOSEQUENCE CM TAPER FILES
- ENDOSEQUENCE RECIPROCATING CM FILES
- ES-CM
- ES-SF
- ESX
- K-FILES
- RACE
- RAZORFLEX NITI
- SCOUTRACE
- XP-3D
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.