Medical device licence · 98414 · Class 2
POWERED SURGICAL INSTRUMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 19, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98414
- Licence holder
- Keystone DentalIrvine, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 19, 2017
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GENESIS DRILL EXTENDER FOR GENESIS IMPLANT SYSTEM
- GENESIS PILOT RETENTION IMPLANT DRIVER, LATCH, GENESIS IMPLANTS
- GENESIS QUAD DRIVER, LATCH TYPE, FOR GENESIS IMPLANT SYSTEM
- IMPLANT DRIVER FOR PRIMASOLO ONE-PIECE IMPLANTS
- IMPLANT DRIVER, TILOBE CONNECTION
- LOCKING DRILL EXTENDER FOR LATCH-TYPE INSTRUMENTS
- PRIMA GUIDED IMPLANT DRIVER, PRIMA TAPERED IMPLANTS
- PRIMA GUIDED TISSUE PUNCH, PRIMA TAPERED IMPLANTS
- QUAD DRIVER, LATCH-TYPE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.