ApprovalTrail

Medical device licence · 92812 · Class 2

SURGICAL DRILL SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed February 11, 2014. It is in Health Canada’s list of active licences.
Licence number
92812
Licence holder
Osstem Implant Co., LtdBusan, South Korea
Risk class
Class II (low to moderate risk)
Licence type
System
First licensed
February 11, 2014
Devices covered
76

Devices on this licence

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

  • 122 TAPER DRILL
  • 123 CORTICAL DRILL
  • 123 GUIDE DRILL
  • 123 TWIST DRILL
  • 485 DRILL
  • ANCHOR DRILL
  • BONE PROFILER
  • CAS DRILL
  • CORTICAL DRILL
  • CORTICAL DRILL 2
  • CORTICAL DRILL 3
  • COUNTERSINK
  • CREST REMOVER
  • DIRECT DRILL
  • DRILL EXTENSION
  • EK CORTICAL DRILL 3
  • EXPANSION DRILL
  • FLATTENING DRILL
  • FLATTENING DRILL(NON-STOPPER)
  • GUIDE DRILL
  • GUIDED INITIAL DRILL
  • GUIDED TWIST DRILL
  • INITIAL DRILL
  • INITIAL DRILL(NON-STOPPER)
  • IV TYPE CORTICAL DRILL
  • IV TYPE TWIST DRILL
  • KS CORTICAL DRILL 3
  • LANCE DRILL
  • LAS DRILL CORE
  • LAS DRILL DOME
  • LAS DRILL WIDE DOME
  • LONG SHANK COUNTERSINK
  • LONG SHANK PILOT DRILL
  • ONE485 DRILL
  • ONE485 PILOT DRILL
  • ONE485 TWIST DRILL
  • ONECAS DRILL
  • ONECAS TWIST DRILL
  • ONEGUIDE PATH DRILL
  • ONEGUIDE PATH DRILL(NON-STOPPER)
  • ONEGUIDE TAPER CORTICAL DRILL
  • ONEGUIDE TAPER DRILL
  • ONEGUIDE TAPER DRILL(NON-STOPPER)
  • ONEGUIDE TWIST DRILL
  • ONEGUIDE TWIST DRILL(NON-STOPPER)
  • ONEMS CORTICAL DRILL
  • ONEMS CORTICAL DRILL(NON-STOPPER)
  • ONEMS DRILL
  • ONEMS DRILL(NON-STOPPER)
  • ONEMS LANCE DRILL
  • ONEMS PATH DRILL
  • ONEMS PATH DRILL(NON-STOPPER)
  • ORTHODONTIC DRILL
  • OSSTEMGUIDE ANCHOR TWIST DRILL
  • OSSTEMGUIDE CORTICAL DRILL
  • OSSTEMGUIDE INITIAL DRILL
  • OSSTEMGUIDE TISSUE PUNCH
  • OSSTEMGUIDE TWIST DRILL
  • PERFORATION DRILL
  • REMOVAL BUR
  • REVERSE DRILL
  • SAW
  • SAW SET
  • SCREW REMOVAL DRILL
  • SET DRILL
  • SIDE WALL DRILL
  • SIDECUT DRILL
  • SMARTGUIDE TWIST DRILL
  • STRAIGHT FIXTURE SURGICAL TAP
  • SURGICAL TAP
  • TAPER CORTICAL DRILL
  • TAPER DRILL
  • TAPER FIXTURE SURGICAL TAP
  • THREE CUTTER TWIST DRILL
  • TREPHINE DRILL
  • TWIST DRILL

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