Medical device licence · 97368 · Class 3
THERMAL OBTURATORS
Yes: licensed in Canada
Licence status Issued (active); first licensed July 26, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97368
- Licence holder
- Us EndodonticsJohnson City, TN, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- July 26, 2016
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ALLFILL
- EDGECORE EDGEENDO
- EDGECORE EDGEENDO PINK GUTTA PERCHA CORE THERMAL OBTURATORS
- EDGECORE FOR EDGEEVOLVE PINK GUTTA PERCHA CORE THERMAL OBTURATORS
- EDGECORE FOR EDGEONE PINK GUTTA PERCHA CORE THERMAL OBTURATORS
- EDGECORE FOR EDGESEQUEL PINK GUTTA PERCHA CORE THERMAL OBTURATORS
- EDGECORE FOR EDGETAPER PINK GUTTA PERCHA CORE THERMAL OBTURATORS
- EDGEFILL EDGEENDO THERMAL PLASTIC OBTURATOR
- EDGEFILL FOR EDGEEVOLVE THERMAL PLASTIC OBTURATOR
- EDGEFILL FOR EDGEONE THERMAL PLASTIC OBTURATOR
- EDGEFILL FOR EDGESEQUEL THERMAL PLASTIC OBTURATOR
- EDGEFILL FOR EDGETAPER THERMAL PLASTIC OBTURATOR
- GUTTAFILL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.