Medical device licence · 89175 · Class 2
ORTHODONTIC HEADGEAR
Yes: licensed in Canada
Licence status Issued (active); first licensed July 3, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89175
- Licence holder
- Great Lakes Dental TechnologiesTonawanda, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- July 3, 2012
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FACE CRIB
- GREAT LAKES NOLA PROTRACTION HEADGEAR FACE MASK
- GREAT LAKES NOLA PROTRACTION HEADGEAR HICKHAM
- GRUMMONS PROTRACTION FACE MASK
- PEDO-ADAPTABLE CLASS III MASK
- STD-ADAPTABLE CLASS III MASK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.