Medical device licence · 98993 · Class 3
ZIRCONIA BLOCK
Yes: licensed in Canada
Licence status Issued (active); first licensed April 20, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98993
- Licence holder
- Shandong Huge Dental Material CorporationRizhao, 120, China
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- April 20, 2017
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ZIRCONIA BLOCK ANTERIOR TRANSLUCENCY (AT)
- ZIRCONIA BLOCK GRADIENT MULTILAYER (GM)
- ZIRCONIA BLOCK HIGH STRENGTH
- ZIRCONIA BLOCK HIGH STRENGTH (HS)
- ZIRCONIA BLOCK HIGH TRANSLUCENCY
- ZIRCONIA BLOCK HIGH TRANSLUCENCY PLUS (HT PLUS)
- ZIRCONIA BLOCK HIGH TRANSLUCENCY(HT)
- ZIRCONIA BLOCK MAXMULTILAYER-4D (MM-4D)
- ZIRCONIA BLOCK MULTI-LAYERED HIGH TRANSLUCENCY (MHT)
- ZIRCONIA BLOCK SUPER TRANSLUCENCY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.