ApprovalTrail

Medical device licence · 85865 · Class 2

SET OPTIMA MX

Yes: licensed in Canada

Licence status Issued (active); first licensed April 19, 2011. It is in Health Canada’s list of active licences.
Licence number
85865
Licence holder
Bien-Air Dental SaBienne, Switzerland
Risk class
Class II (low to moderate risk)
Licence type
Device Group Family
First licensed
April 19, 2011
Devices covered
11

Devices on this licence

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

  • SET OPTIMA MX INT
  • SET OPTIMA MX INT BASIC
  • SET OPTIMA MX INT BASIC+TR
  • SET OPTIMA MX INT+TR
  • SET OPTIMA MX2 INT DMX3 2M
  • SET OPTIMA MX2 INT PLUS
  • SET OPTIMA MX2 INT PLUS+TR
  • SET OPTIMA MX2 INT PRO
  • SET OPTIMA MX2 INT PRO 2M
  • SET OPTIMA MX2 INT PRO+24V-32V
  • SET OPTIMA MX2 INT PRO+TR

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