Medical device licence · 103450 · Class 2
ORTHODONTIC ALIGNERS
Yes: licensed in Canada
Licence status Issued (active); first licensed August 15, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103450
- Licence holder
- Ortho Organizers Inc.Savannah, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 15, 2019
- Devices covered
- 20
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ATTACHMENT PLACEMENT ALIGNER
- CUSTOM-MADE ALIGNER
- PASSIVE APPLIANCE
- REPRODUCTION ALIGNER
- RETAINER APPLIANCE
- REVEAL ALIGNERS - EXPRESS
- REVEAL ALIGNERS - LITE
- REVEAL ALIGNERS - REFINEMENTS
- REVEAL ALIGNERS - STANDARD
- REVEAL CLEAR ALIGNER REMAKE
- REVEAL CLEAR ALIGNER RETAINER
- REVEAL CLEAR ALIGNER RETAINERS
- REVEAL CLEAR ALIGNERS
- REVEAL CLEAR ALIGNERS EXPRESS
- REVEAL CLEAR ALIGNERS FLEX
- REVEAL CLEAR ALIGNERS LITE
- REVEAL CLEAR ALIGNERS STANDARD
- REVEAL RETAINER SINGLE ARCH
- REVEAL RETAINER U/L ARCH
- SLX CLEAR ALIGNERS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.