Medical device licence · 113971 · Class 2
IBT
Yes: licensed in Canada
Licence status Issued (active); first licensed September 15, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113971
- Licence holder
- Specialty AppliancesCumming, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- September 15, 2025
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3-D IB - DUAL ARCH
- 3-D IB - SINGLE ARCH
- IB TRAYS ONLY PER ARCH
- LABIAL INDIRECT PER TOOTH: LOWER
- LABIAL INDIRECT PER TOOTH: UPPER
- LINGUAL INDIRECT PER TOOTH: LOWER
- LINGUAL INDIRECT PER TOOTH: UPPER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.