Medical device licence · 13049 · Class 3
AMALGAM CAPSULE SYSTEM
No longer licensed: cancelled: quality-system requirement (2003)
Licence status Cancelled: quality-system requirement (2003); first licensed October 21, 1999; ended February 16, 2004. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 13049
- Licence holder
- SDI LimitedBayswater, VIC, Australia
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- October 21, 1999
- Ended
- February 16, 2004
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AMALGAM CAPSULE SYSTEM - GS80 AMALGAM CAPSULES
- AMALGAM CAPSULE SYSTEM - LOJIC+ AMALGAM CAPSULES
- AMALGAM CAPSULE SYSTEM - LOJIC+ AMALGAM DP CAPSULES
- AMALGAM CAPSULE SYSTEM - PATTERSON DENTAL ADMIX ALLOY AMALGAM
- AMALGAM CAPSULE SYSTEM - PATTERSON DENTAL SPHERICAL ALLOY AMALGAM
- AMALGAM CAPSULE SYSTEM - PERMITE C AMALGAM CAPSULES
- AMALGAM CAPSULE SYSTEM PERMITE C AMALGAM DP CAPSULES
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.