ApprovalTrail

Medical device licence · 89067 · Class 3

GENESIS IMPLANT SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed June 20, 2012. It is in Health Canada’s list of active licences.
Licence number
89067
Licence holder
Keystone DentalIrvine, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 20, 2012
Devices covered
11

Devices on this licence

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

  • GENESIS IMPLANT SYSTEM - COVER SCREW
  • GENESIS IMPLANT SYSTEM - ESTHETIC CONTOUR TI
  • GENESIS IMPLANT SYSTEM - GENESIS STRAIGHT IMPLANT BIOSPARK SURFACE
  • GENESIS IMPLANT SYSTEM - HEALING ABUTMENT
  • GENESIS IMPLANT SYSTEM - LOCATOR ABUTMENT ASSEMBLY
  • GENESIS IMPLANT SYSTEM - SNAP ABUTMENT ASSEMBLY
  • GENESIS IMPLANT SYSTEM - SURCONNECT ABUTMENT
  • GENESIS IMPLANT SYSTEM - TEMPORARY ABUTMENT
  • GENESIS IMPLANT SYSTEM - TI TEMPORARY ABUTMENT
  • GENESIS IMPLANT SYSTEM - UCLA GOLD/PLASTIC SLEEVE
  • GENESIS IMPLANT SYSTEM -FINAL ABUTMENT SCREW

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