Medical device licence · 99833 · Class 3
HARMONIZE NANOHYBRID UNIVERSAL COMPOSITE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 19, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 99833
- Licence holder
- Kerr CorporationOrange, California, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- October 19, 2017
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DENTIN, HARMONIZE UNIVERSAL COMPOSITE
- ENAMEL, HARMONIZE UNIVERSAL COMPOSITE
- HARMONIZE A2 ENAMEL UNIDOSE, SAMPLE
- HARMONIZE DENTIN
- HARMONIZE ENAMEL
- HARMONIZE INCISAL
- TRANSLUCENT INCISAL, HARMONIZE UNIVERSAL COMPOSITE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.