Medical device licence · 95579 · Class 2
ORTHODONTIC HEADGEAR
Yes: licensed in Canada
Licence status Issued (active); first licensed August 14, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95579
- Licence holder
- Gc Orthodontics America Inc.Alsip, IL, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 14, 2015
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DISTAL LOOP PAB
- EXPR LIP BUMPER NATURAL
- FCBW MEDIUM
- FCBW SHORT
- LIP BUMPER NATURAL
- MESIAL LOOP PAB
- PREFORMED FLAT LABIAL BOW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.