ApprovalTrail

Medical device licence · 100413 · Class 3

GUTTA PERCHA POINTS

Yes: licensed in Canada

Licence status Issued (active); first licensed January 30, 2018. It is in Health Canada’s list of active licences.
Licence number
100413
Licence holder
ColteneLangenau, Germany
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
January 30, 2018
Devices covered
11

Devices on this licence

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

  • HYFLEX CM GUTTAPERCHA POINTS
  • HYFLEX EDM GUTTAPERCHA POINTS
  • HYGENIC CLASSIC GUTTA PERCHA POINTS
  • HYGENIC GUTTA PERCHA POINTS AAE/ISO
  • HYGENIC GUTTA PERCHA POINTS ADA
  • HYGENIC GUTTAPERCHA POINTS GREATER TAPER
  • ROEKO GUTTAPERCHA POINTS COLOR
  • ROEKO GUTTAPERCHA POINTS CONVENTIONAL
  • ROEKO GUTTAPERCHA POINTS GREATER TAPER
  • ROEKO GUTTAPERCHA POINTS ISO
  • ROEKO GUTTAPERCHA POINTS TOP COLOR

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