ApprovalTrail

Medical device licence · 101330 · Class 3

DENTAL ATTACHMENTS/RESTORATIVE

Yes: licensed in Canada

Licence status Issued (active); first licensed June 29, 2018. It is in Health Canada’s list of active licences.
Licence number
101330
Licence holder
Oco Biomedical, Inc.Albuquerque, NM, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
June 29, 2018
Devices covered
7

Devices on this licence

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

  • 2PC SOLID ABUTMENT
  • ENGAGE CROWN & BRIDGE SOLID ABUTMENT
  • ENGAGE CUSTOM ANGLED ABUTMENT
  • ENGAGE HEALING ABUTMENT
  • ENGAGE O-BALL ABUTMENT
  • FLUSH HEALING SCREW
  • IMPRESSION COPING/TEMPORARY ABUTMENT

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