Medical device licence · 98158 · Class 3
SOLEA 2.0
Yes: licensed in Canada
Licence status Issued (active); first licensed December 2, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 98158
- Licence holder
- Convergent Dental, Inc.Waltham, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 2, 2016
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 15/600 HOLLOW WAVEGUIDE
- 8/1200 HOLLOW WAVEGUIDE
- 8/600 HOLLOW WAVEGUIDE
- CONTRA ANGLE HANDPIECE
- SOLEA 2.0 (W/O COMPRESSOR)
- SOLEA 2.0 (WITH COMPRESSOR)
- STRAIGHT HANDPIECE
- ULTRAGUIDE AUTO ALIGNMENT SYSTEM
- ULTRAGUIDE HANDPIECE
- ULTRAGUIDE STARTER KIT
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.