Medical device licence · 67509 · Class 3
INTERNAL IMPLANT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed February 17, 2005. It is in Health Canada’s list of active licences.
- Licence number
- 67509
- Licence holder
- Biohorizons Implant Systems Inc.Birmingham, AL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- February 17, 2005
- Devices covered
- 19
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INTERNAL IMPLANT SYSTEM - ABUTMENT FOR SCREW-RETAINED BAR COVER CAP
- INTERNAL IMPLANT SYSTEM - ABUTMENT FOR SCREW-RETAINED BAR GOLD COPING
- INTERNAL IMPLANT SYSTEM - ABUTMENT FOR SCREW-RETAINED BAR SCREW
- INTERNAL IMPLANT SYSTEM - ABUTMENT SCREW
- INTERNAL IMPLANT SYSTEM - ATTACHMENT HOUSINGS - TITANIUM
- INTERNAL IMPLANT SYSTEM - BALL ATTACHMENT SET
- INTERNAL IMPLANT SYSTEM - CLOSED TRAY COPING
- INTERNAL IMPLANT SYSTEM - COMFORT CAP
- INTERNAL IMPLANT SYSTEM - COVER CAP
- INTERNAL IMPLANT SYSTEM - DIRECTIONAL RINGS
- INTERNAL IMPLANT SYSTEM - IMPLANT HA, LASER-LOK
- INTERNAL IMPLANT SYSTEM - NYLON INSERT
- INTERNAL IMPLANT SYSTEM - O-RING
- INTERNAL IMPLANT SYSTEM - SIMPLE SOLUTIONS KIT, HIGH COLLAR
- INTERNAL IMPLANT SYSTEM - SURGICAL KIT
- INTERNAL IMPLANT SYSTEM - WIDE EMERGENCE PROFILE ABUTMENT
- INTERNAL PLASTIC ANGLED TEMPORARY ABUTMENT
- PEEK TEMPORARY CYLINDER, HEXED
- PEEK TEMPORARY CYLINDER, NON-HEXED
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.