Medical device licence · 102315 · Class 2
SPARK CLEAR ALIGNER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed January 29, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102315
- Licence holder
- Ormco CorporationBrea, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- January 29, 2019
- Devices covered
- 14
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SPARK 10
- SPARK 15
- SPARK 20
- SPARK 25
- SPARK 35
- SPARK ADVANCED
- SPARK COMBO 10
- SPARK COMBO 20
- SPARK COMBO ADVANCED
- SPARK JUNIOR PHASE 1
- SPARK JUNIOR PHASE 2
- SPARK ON DEMAND ACTIVE ALIGNER
- SPARK ON DEMAND PASSIVE ALIGNER
- SPARK ONE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.