Medical device licence · 92813 · Class 2
SURGICAL DRIVER 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
- 92813
- Licence holder
- Osstem Implant Co., LtdBusan, South Korea
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- February 11, 2014
- Devices covered
- 27
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADAPTER
- BONE SCREW MACHINE DRIVER
- BONE SPREADER
- EK NOMOUNT DRIVER
- ET NOMOUNT DRIVER
- EXCELLENT SOLID DRIVER
- EXP MOUNT DRIVER
- HEX DRIVER
- KS NOMOUNT DRIVER
- MACHINE DRIVER FOR DENTURE
- MACHINE DRIVER FOR NARROW RIDGE
- MACHINE SCREW DRIVER
- MOUNT DRIVER
- MS NARROW RIDGE NOMOUNT DRIVER
- MS PORT DRIVER
- MULTI ABUTMENT MACHINE DRIVER
- NOMOUNT DRIVER
- ONEGUIDE MOUNT DRIVER
- ONEGUIDE SS NOMOUNT DRIVER
- ONEGUIDE US NOMOUNT DRIVER
- ORTHODONTIC SCREW MACHINE DRIVER
- ORTHODONTIC SCREW REMOVAL TOOL
- RIGID DRIVER
- SOLID DRIVER
- SS NOMOUNT DRIVER
- TS NOMOUNT DRIVER
- US NOMOUNT DRIVER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.