ApprovalTrail

Medical device licence · 29797 · Class 2

FILE-EZE

Yes: licensed in Canada

Licence status Issued (active); first licensed May 28, 2001. It is in Health Canada’s list of active licences.
Licence number
29797
Licence holder
Ultradent Products Inc.South Jordan, Utah, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
May 28, 2001
Devices covered
4

Devices on this licence

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

  • FILE-EZE 1.2 ML UNIT DOSE SYRINGES FOR INDISPENSE LOADING
  • FILE-EZE INDISPENSE REFILL
  • FILE-EZE KIT
  • FILE-EZE REFILL

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