Medical device licence · 111120 · Class 3
GENESIS ACTIVE IMPLANT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 19, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111120
- Licence holder
- Keystone DentalIrvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 19, 2024
- Devices covered
- 43
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AESTHETIC PEEK STRAIGHT TEMP ABUTMENT
- ANGLEBASE ENGAGING. CONCAVE, CUFF
- ANGLEBASE NON-ENGAGING, CONCAVE, CUFF
- ANGLED AESTHETIC PEEK TEMPORARY ABUTMENT
- ANGLED MULTI-UNIT ABUTMENT SCREW, RP/WP
- CONCAVE HEALING ABUTMENT
- CONICAL CONNECTION IMPLANT ANATITE/ BIOSPARK
- CONICAL IMPLANT DRIVER
- COUNTERSINK
- COUNTERSINK PACK
- COVER SCREW
- ELLIPTIBASE ENGAGING, CUFF
- ELLIPTIBASE ENGAGING, CUFF
- FINAL ABUTMENT SCREW
- FLARED HEALING ABUTMENT
- GENESIS FINAL TAPERED DRILL DLC COATED
- GENESIS FULL DEPTH TWIST DRILL
- GUIDED IMPLANT DRIVER
- HEX PROSTHETIC DRIVER
- IT ABUTMENT DRIVER
- MULTI-UNIT ABUTMENT, RP
- MULTI-UNIT ABUTMENT, WP
- MULTI-UNIT ANGLEBASE, RP
- MULTI-UNIT ANGLEBASE, WP
- MULTI-UNIT ANGLED ABUTMENT TORX SCREW
- MULTI-UNIT FINAL PROSTHETIC SCREW, RP
- MULTI-UNIT FINAL PROSTHETIC SCREW, WP
- MULTI-UNIT HEALING CAP, WP
- MULTI-UNIT HEALING CAP,RP
- MULTI-UNIT TEMPORARY ABUTMENT, RP
- MULTI-UNIT TEMPORARY ABUTMENT, WP
- PEEK TEMPORARY ABUTMENT, ENGAGING
- PEEK TEMPORARY ABUTMENT, NON-ENGAGING
- TI BASE ENGAGING, CONCAVE, CUFF
- TI BASE NON-ENGAGING, CONCAVE, CUFF
- TIPINK 20 DEGREE ANGLED AESTHETIC ABUTMENT
- TIPINK IMMEDIATE TEMP ABUTMENT, PEEK CAP
- TIPINK STRAIGHT AESTHETIC ABUTMENT
- TIPINK TEMPORARY ABUTMENT, ENGAGING
- TIPINK TEMPORARY ABUTMENT, NON-ENGAGING
- TITANIUM BLANK, PREMILLED
- TORX BALL SCREWDRIVER
- TORX SCREW ELLIPTIBASE/ANGLEBASE ABUTMENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.