ApprovalTrail

Medical device licence · 12509 · Class 3

UNIVERSAL COMPOSITES

No longer licensed: cancelled

Licence status Cancelled; first licensed September 24, 1999; ended December 7, 2021. It is in Health Canada’s archive of licences no longer in force.
Licence number
12509
Licence holder
Kulzer GmbhSouth Bend, IN, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Group Family
First licensed
September 24, 1999
Ended
December 7, 2021
Devices covered
9

Devices on this licence

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

  • CHARISMA COMPAC TRAY
  • CHARISMA F GLOBAL TRAY
  • CHARISMA PLT UNIVERSAL COMPOSITE (PRELOADED)
  • CHARISMA PRESS DISPENSER
  • CHARISMA SHADE GUIDE
  • CHARISMA SHADE SUPERLIGHT
  • CHARISMA SHADE UNIVERSAL COMPOSITE
  • CHARISMA SINGLE DOSE ASST.
  • EFFECT COLOR SHADE UNIVERSAL COMPOSITE

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