Medical device licence · 85829 · Class 3
ZYGOMATIC IMPLANT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 18, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 85829
- Licence holder
- Southern Implants Pty Ltd.Irene, South Africa
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 18, 2011
- Devices covered
- 24
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMPACT CONCICAL ABUTMENT
- COMPACT CONICAL ABUTMENT FOR ZYGIN
- COVER SCREW
- COVERSCREW FOR ZYGIN
- EXHEX
- EXHEX ONC
- EXHEX ZYG
- EXHEX ZYGAN
- EXHEX ZYGIN
- SCREW-RETAINED ABUTMENT FOR ZYGOMATIC IMPLANTS
- SCREW-RETAINED ABUTMENT FOR ZYGOMATIC IMPLANTS FOR EX-HEX
- SCREW-RETAINED ABUTMENT, TI
- STRAUMANN ZYGOMATIC IMPLANT, ZAGA FLAT
- STRAUMANN ZYGOMATIC IMPLANT, ZAGA ROUND
- ZAGA FLAT ZYGOMATIC IMPLANT
- ZAGA ROUND ZYGOMATIC IMPLANT
- ZYGOMATIC IMPLANT SYSTEM - 55 DEGREES PLATFORM IMPLANT
- ZYGOMATIC IMPLANT SYSTEM - COUNTERSINK
- ZYGOMATIC IMPLANT SYSTEM - DRILL
- ZYGOMATIC IMPLANT SYSTEM - INSTRUMENT TRAY
- ZYGOMATIC IMPLANT SYSTEM - ONION DRIVER
- ZYGOMATIC IMPLANT SYSTEM - ROUND BUR
- ZYGOMATIC IMPLANT SYSTEM - SURGICAL KIT - FINISHED
- ZYGOMATIC IMPLANT SYSTEM - TRY-IN IMPLANT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.