Medical device licence · 30968 · Class 3
RESIN-LUTING CEMENT
Yes: licensed in Canada
Licence status Issued (active); first licensed July 31, 2001. It is in Health Canada’s list of active licences.
- Licence number
- 30968
- Licence holder
- Bisco, Inc.Schaumburg, Illinois, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- July 31, 2001
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BISCEM OPAQUE DUAL SYRINGE KIT
- BISCEM TRANSLUCENT DUAL SYRINGE KIT
- C&B CEMENT
- CHOICE 2 CEMENT
- CHOICE CEMENT
- DUO-LINK CEMENT
- DUO-LINK UNIVERSAL
- ECEMENT DC
- ECEMENT LC
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.