Medical device licence · 90474 · Class 2
TOOTH POSITIONERS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 8, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 90474
- Licence holder
- Great Lakes Dental TechnologiesTonawanda, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 8, 2013
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CUSTOM APPLIANCE
- CUSTOM ELASTODONTIC APPLIANCE
- CUSTOM POSITION
- ELAST ALIGNER OVER BRACKETS
- ELASTO ALIGNER
- ELASTO ALIGNER NO ATTACHMENTS
- ELASTODONTIC REMAKE
- ELASTODONTIC REPAIR
- ELASTODONTIC SET-UP ONLY
- OSAMU FUNCTIONAL APPLIANCE
- POSITIONER
- SMART MOVE ALIGNERS
- SMART MOVES REMAKE
- SMART MOVES REPAIR
- YOSHII RETAINER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.