Medical device licence · 97038 · Class 2
SPACEFILE INTERPROXIMAL REDUCTION SYSTEM
No longer licensed: discontinued at renewal
Licence status Discontinued at renewal; first licensed May 31, 2016; ended October 21, 2020. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 97038
- Licence holder
- Dentsply Sirona Orthodontics Inc.Sarasota, FL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 31, 2016
- Ended
- October 21, 2020
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPACEFILE IPR AIR MOTOR CMPLX AM
- SPACEFILE IPR CONTRA ANGLE CMPLX
- SPACEFILE IPR CONTRA-ANGLE HANDPIECE AND AIR MOTOR KIT
- SPACEFILE IPR CONTRA-ANGLE HANDPIECE KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.