Medical device licence · 111510 · Class 2
TIBASE
Yes: licensed in Canada
Licence status Issued (active); first licensed July 16, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111510
- Licence holder
- Smart Denture Conversions, LlcApex, NC, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 16, 2024
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CEMENTABLE TIBASE
- PRE-COATED TIBASE
- PREMIUM STARTER KIT
- RECHARGE KIT W/ POC
- RECHARGE KIT W/ TALL SPARE PARTS
- SEPARABLE FASTENER ASSEMBLY
- STANDARD TIBASE
- STARTER KIT
- TALL SPARE PARTS KIT
- TALL TIBASE
- TEMPORARY CYLINDER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.