Medical device licence · 63640 · Class 2
PLASTIC ORTHODONTIC BRACKETS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 30, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 63640
- Licence holder
- Ortho Organizers Inc.Savannah, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 30, 2004
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CLASSONE COMPOSITE EDGEWISE (GOLD SLOT) BRACKETS
- CLASSONE COMPOSITE ROTH (GOLD SLOT) BRACKETS
- CLASSONE COMPOSITE ROTH (GOLD SLOT) BRACKETS WITH HOOK
- COMPOSITE ROTH NO METAL SLOT
- COMPOSITE ROTH NO METAL SLOT HK
- ENVISION
- OYSTER BRACKETS
- PLASTIC EDGEWISE BRACKETS
- QUANTUM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.