ApprovalTrail

Medical device licence · 64002 · Class 2

DENTAL FILES

Yes: licensed in Canada

Licence status Issued (active); first licensed March 25, 2004. It is in Health Canada’s list of active licences.
Licence number
64002
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
March 25, 2004
Devices covered
9

Devices on this licence

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

  • GT ROTARY FILES
  • GT SERIES X ROTARY FILES
  • PATHFILE ROTARY FILE
  • PATHFILE ROTARY FILE ASSORTED
  • PATHFILE ROTARY FILE ASSORTED DEMO PRODUCT
  • PROFILE ROTARY FILES
  • PROFILE SERIES X
  • PROTAPER UNIVERSAL ROTARY FILES
  • PROTAPER UNIVERSAL ROTARY RETREATMENT FILES

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