Medical device licence · 96793 · Class 3
DENTAL AMALGAM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 6, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 96793
- Licence holder
- DMG America, LLCEnglewood, NJ, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- April 6, 2016
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ZENITHDENTAL PREMIUM DISPERSED PHASEDENTAL AMALGAM ALLOY
- ZENITHDENTAL ROYALE DISPERSED PHASE HIGH-COPPER DENTAL AMALGAM ALLOY
- ZENITHDENTAL TYPE-T HIGH-COPPER SPHERICAL DENTAL AMALGAM ALLOY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.