Medical device licence · 113867 · Class 2
INVISIBLE RETAINER
Yes: licensed in Canada
Licence status Issued (active); first licensed August 26, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113867
- Licence holder
- Specialty AppliancesCumming, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- August 26, 2025
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DUAL ARCH INVISIBLE RETAINER
- G2 DUAL (FINISHING PKG)
- G2 SINGLE (FINISHING PKG)
- GUARDIAN 1 - DUAL ARCH
- GUARDIAN 1 - SINGLE ARCH
- GUARDIAN 2 - DUAL ARCH
- GUARDIAN 2 - SINGLE ARCH
- GUARDIAN 3 - DUAL ARCH
- GUARDIAN 3 - SINGLE ARCH
- GUARDIAN 4 - DUAL ARCH
- GUARDIAN 4 - SINGLE ARCH
- IR DUAL (FINISHING PKG)
- IR EXPRESS DUAL ARCH
- IR EXPRESS SINGLE ARCH
- IR SINGLE (FINISHING PKG)
- PRE GUARDIAN - DUAL ARCH
- PRE GUARDIAN - SINGLE ARCH
- SINGLE ARCH INVISIBLE RETAINER
- THEROUX PHASE ONE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.