ApprovalTrail

Medical device licence · 104145 · Class 2

SINGLE PATIENT DRILLS

Yes: licensed in Canada

Licence status Issued (active); first licensed January 10, 2020. It is in Health Canada’s list of active licences.
Licence number
104145
Licence holder
Zimvie Us Corp Llc.Palm Beach Gardens, FL, United States
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
January 10, 2020
Devices covered
17

Devices on this licence

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

  • DRIVA GOLD SERIES DRILLS DRILL, SINGLE PATIENT
  • DRIVA GOLD SERIES DRILLS ROUND BUR
  • DRIVA GOLD SERIES DRILLS STEP DRILL, SINGLE PATIENT
  • DRIVA GOLD SERIES DRILLS TAPERED PILOT DRILL, SINGLE PATIENT
  • SINGLE PATIENT ACT POINTED STARTER DRILL
  • SINGLE PATIENT ACT TWIST DRILL
  • SINGLE PATIENT CERTAIN COUNTERSINK DRILL
  • SINGLE PATIENT COUNTERSINK DRILL
  • SINGLE PATIENT COUNTERSINK/PILOT DRILL
  • SINGLE PATIENT FLAT BOTTOM COUNTERSINK SHAPING DRILL
  • SINGLE PATIENT IMMEDIATE MOLAR SHAPING DRILL
  • SINGLE PATIENT IMMEDIATE MOLAR STARTER DRILL
  • SINGLE PATIENT IMMEDIATE MOLAR TAPERED DRILL T3 PRO
  • SINGLE PATIENT IMMEDIATE MOLAR TAPERED DRILL TSX
  • SINGLE PATIENT PILOT DRILL
  • SINGLE PATIENT QUAD SHAPING DRILL
  • SINGLE PATIENT STAINLESS STEEL ROUND DRILL

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