Medical device licence · 90469 · Class 2
SPECIALTY-CUSTOM APPLIANCES
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
- 90469
- 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
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BLEACHING TRAY
- CUSTOM IMPRESSION TRAY-1 ARCH
- FLUORIDE/CUSTOM IMP TRAY
- INDIRECT BONDING
- MOUTHGUARD
- PERIO PROTECT CUSTOM ORDER
- PERIO PROTECT TRAY
- PERIO PROTECT TRAY REMAKE
- SOFT NIGHTGUARD
- SOFT POSTERIOR BIT/PLATE
- UNCUT BIOLAST-BIOCRYL-EVA(1
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.