Medical device licence · 102404 · Class 3
SOLEA
Yes: licensed in Canada
Licence status Issued (active); first licensed February 15, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102404
- Licence holder
- Convergent Dental, Inc.Waltham, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 15, 2019
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CONTRA ANGLE HANDPIECE MODEL 3.0
- SOLEA
- SOLEA PROTECT HANDPIECE KIT MODEL 3.0
- STRAIGHT HANDPIECE MODEL 3.0
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “solea”. A notice may cover another product or only some lots: read it to see what it covers.
- SoleaSeptember 20, 2023 · Dental · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.