Medical device licence · 83172 · Class 2
INTRAORAL DIGITAL SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 25, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 83172
- Licence holder
- Cefla S.C.Imola, BO, Italy
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- June 25, 2010
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BIOLASE DAVINCI ISENSOR #1
- BIOLASE DAVINCI ISENSOR #2
- BIOLASE DAVINCI ISENSOR DUO
- ZEN-X
- ZEN-X 1
- ZEN-X 2
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.