Medical device licence · 65538 · Class 3
LIGHT-CURED FLOWABLE COMPOSITES
Yes: licensed in Canada
Licence status Issued (active); first licensed August 19, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 65538
- Licence holder
- GC America Inc.Alsip, Illinois, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- August 19, 2004
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GRADIA DIRECT FLO
- GRADIA DIRECT LOFLO
- UNIFIL FLOW REFILL RESTORATIVE RESIN
- UNIFIL FLOW STARTER PACKAGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.