Medical device licence · 71876 · Class 3
TISSUE LEVEL IMPLANT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 17, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 71876
- Licence holder
- Biohorizons Implant Systems Inc.Birmingham, AL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 17, 2006
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INTERNAL/TISSUE LEVEL ABUTMENT SCREW
- INTERNAL/TISSUE LEVEL DIRECT COPING SCREW
- SINGLE-STAGE IMPLANT SYSTEM - CUSTOM CAST ABUTMENT SLEEVE
- SINGLE-STAGE IMPLANT SYSTEM - IMPLANT HA, LASER-LOK
- SINGLE-STAGE IMPLANT SYSTEM - PLATFORM HA
- SINGLE-STAGE IMPLANT SYSTEM - SIMPLE SOLUTIONS ABUTMENT
- SINGLE-STAGE IMPLANT SYSTEM - SIMPLE SOLUTIONS KIT
- TISSUE LEVEL ANGLED ABUTMENT
- TISSUE LEVEL CUSTOM CAST ABUTMENT
- TISSUE LEVEL DIRECT COPING
- TISSUE LEVEL HEALING ABUTMENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.