Medical device licence · 64945 · Class 2
FUJI ORTHODONTIC CEMENT
Yes: licensed in Canada
Licence status Issued (active); first licensed June 29, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64945
- Licence holder
- GC America Inc.Alsip, Illinois, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Group Family
- First licensed
- June 29, 2004
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FUJI ORTHO LC CAPSULE PACKAGE
- FUJI ORTHO LC PASTE PAK AUTOMIX SET
- FUJI ORTHO LC PASTE PAK REFILL
- FUJI ORTHO LC STARTER KIT
- FUJI ORTHO LIQUID
- FUJI ORTHO PACKAGES
- FUJI ORTHO POWDER
- GC ORTHO CONDITIONER
- GEL CONDITIONER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.