ApprovalTrail

Medical device licence · 80009 · Class 3

TEMPOSIL 2

Yes: licensed in Canada

Licence status Issued (active); first licensed June 19, 2009. It is in Health Canada’s list of active licences.
Licence number
80009
Licence holder
ColteneLangenau, Germany
Risk class
Class III (moderate to high risk)
Licence type
Device Group Family
First licensed
June 19, 2009
Devices covered
5

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • TEMPOSIL 2 DENTIN INTRO KIT
  • TEMPOSIL 2 DENTIN REFILL
  • TEMPOSIL 2 TRIAL KIT
  • TEMPOSIL 2 WHITE INTRO KIT
  • TEMPOSIL 2 WHITE REFILL

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.