Medical device licence · 38470 · Class 2
ENGINE FILES
Yes: licensed in Canada
Licence status Issued (active); first licensed May 23, 2002. It is in Health Canada’s list of active licences.
- Licence number
- 38470
- Licence holder
- Kerr CorporationOrange, California, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 23, 2002
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONDENSER
- K3 FILES
- K3XF ROTARY NICKEL TITANIUM FILE
- NT ENGINE FILES (ENDONTIC FILES)
- QUANTEC AXXESS ENGINE FILES
- QUANTEC ENGINE FILES
- QUANTEC HAND FILES
- SPREADER
- TF ADAPTIVE ROTARY FILE
- TF ROTARY NICKEL TITANIUM FILES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.