Medical device licence · 115394 · Class 2
CUSTOMIZED ORTHODONTIC PROSTHESIS
Yes: licensed in Canada
Licence status Issued (active); first licensed May 13, 2026. It is in Health Canada’s list of active licences.
- Licence number
- 115394
- Licence holder
- Zh Graceful Dental Lab Co., LtdZhuhai, 190, China
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- May 13, 2026
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CUSTOMIZED ORTHODONTIC PROSTHESIS NIGHT GUARD
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.