Medical device licence · 109414 · Class 2
X-SMART
Yes: licensed in Canada
Licence status Issued (active); first licensed May 31, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109414
- Licence holder
- Sirona Dental Systems GmbhBensheim, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- May 31, 2023
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AL FILE CLIP
- AL LIP CLIP
- APEX FILE CLAMP CABLE L280
- APEX LIP CLIP CABLE L279
- CABLE APEXLOCATOR ENDO TT
- CABLE SET APEX ENDO TT CPL.
- ENDO TABLE TOP, POWER SUPPLY
- INSULATION SLEEVE ENDO 5:1
- MUCOUS MEMBRANE ELECTRODE
- X-SMART 5:1 AL
- X-SMART 5:1 AL KIT
- X-SMART MOTOR HANDPIECE
- X-SMART MOTOR, HANDPIECE SHEATH
- X-SMART PRO
- X-SMART PRO+
- X-SMART, TABLETOP BATTERY PACK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.