Medical device licence · 97705 · Class 3
TILOBEMAXX
Yes: licensed in Canada
Licence status Issued (active); first licensed September 14, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97705
- Licence holder
- Keystone DentalIrvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 14, 2016
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 2.0MM INITIAL DRILL
- BONE TAP TILOBEMAXX/I-HEXMRT IMPLANTS
- HEALING ABUTMENT TILOBEMAXX
- IMPLANT DRIVER, LATCH
- IMPLANT DRIVERS
- PROFILE GAUGE TILOBEMAXX/I-HEXMRT IMPLANTS
- QUAD DRIVER ACCUTORQUE FOR TILOBEMAXX GENESIS.PRIMA PLUS. PRIMA PLUSCONNEX IMPLANTS
- QUAD DRIVER SWIVEL HEAD FOR TILOBEMAXX GENESIS.PRIMA PLUS. PRIMA PLUSCONNEX IMPLANTS
- RATCHET ADAPTER FOR TAPS AND IMPLANT DRIVER
- RATCHET ADAPTER TILOBEMAXX/I-HEXMRT IMPLANTS
- ROUND BURR, TILOBEMAXX/I-HEXMRT IMPLANTS
- SURGICAL RATCHET
- SURGICAL TRAY TILOBEMAXX AND I-HEXMRT IMPLANT SYSTEMS
- TAPERED DRILL TILOBEMAXX/I-HEXMRT IMPLANTS
- TILOBEMAXX COSMETIC ABUTMENT
- TILOBEMAXX COVER SCREW
- TILOBEMAXX IMPLANT
- TILOBEMAXX SURGICAL KIT
- TILOBEMAXX TI TEMPORARY SLEEVE WD
- TILOBEMAXX UCLA GOLD PLASTIC SLEEVE WD
- TWIST DRILL, TILOBEMAXX/I-HEXMRT IMPLANTS
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.