ApprovalTrail

Medical device licence · 37448 · Class 2

POWERED DENTAL HANDPIECES

Yes: licensed in Canada

Licence status Issued (active); first licensed September 24, 1999. It is in Health Canada’s list of active licences.
Licence number
37448
Licence holder
Sirona Dental Systems GmbhBensheim, Germany
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
September 24, 1999
Devices covered
19

Devices on this licence

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

  • ENDO 6:1 HANDPIECE
  • IMPLANT POWERED HANDPIECE
  • MIDWEST ENDO 6:1
  • MIDWEST ENERGO EVA 11
  • MIDWEST ENERGO PROPHY
  • MIDWEST ENERGO SH 1:1 L
  • MIDWEST T1 ENERGO
  • MIDWEST T2 ENERGO
  • SIRONITI AIR PLUS APEX
  • SIRONITI APEX HANDPIECE
  • SIROPURE HANDPIECES
  • T1 CLASSIC HANDPIECES CONTRA-ANGLE
  • T1 CLASSIC HANDPIECES STRAIGHT
  • T1 LINE C
  • T1 LINE ENDO 6 L
  • T1 LINE H
  • T1 LINE HANDPIECES CONTRA-ANGLE
  • T2 LINE A
  • T2 LINE AH

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