ApprovalTrail

Medical device licence · 62588 · Class 2

SOFRELINER TOUGH

Yes: licensed in Canada

Licence status Issued (active); first licensed May 27, 2003. It is in Health Canada’s list of active licences.
Licence number
62588
Licence holder
Tokuyama Dental CorporationTokyo, 13, Japan
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
May 27, 2003
Devices covered
5

Devices on this licence

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

  • SOFRELINER TOUGH FINISHING POINT
  • SOFRELINER TOUGH M KIT
  • SOFRELINER TOUGH M PASTE
  • SOFRELINER TOUGH PRIMER
  • SOFRELINER TOUGH SHAPE ADJUSTMENT POINT

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