Medical device licence · 62342 · Class 3
TOOTH SHADE RESINS
Yes: licensed in Canada
Licence status Issued (active); first licensed April 30, 2003. It is in Health Canada’s list of active licences.
- Licence number
- 62342
- Licence holder
- ColteneLangenau, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- April 30, 2003
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COOL TEMP
- MIRIS DENTIN
- MIRIS EFFECTCOLOR
- MIRIS ENAMEL
- PARACORE
- SYNERGY COMPACT
- SYNERGY COMPACT TWINPACK
- SYNERGY D6 CONNECT
- SYNERGY D6 FLOW INTRO KIT
- SYNERGY D6 SYRINGES REFILLS DENTIN
- SYNERGY D6 SYRINGES REFILLS DENTIN WHITE BLEACH
- SYNERGY D6 SYRINGES REFILLS ENAMEL UNIVERSAL
- SYNERGY D6 SYRINGES REFILLS ENAMEL WHITE OPALESCENT
- SYNERGY D6 TIPS REFILLS DENTIN
- SYNERGY D6 TIPS REFILLS DENTIN WHITE BLEACH
- SYNERGY D6 TIPS REFILLS ENAMEL UNIVERSAL
- SYNERGY D6 TIPS REFILLS ENAMEL WHITE OPALESCENT
- SYNERGY DUO SHADE
- SYNERGY FLOW
- SYNERGY SUPER WHITE
- SYNERGY TRANSPARENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.