Medical device licence · 102583 · Class 3
PROVATA IMPLANT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed March 19, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 102583
- Licence holder
- Southern Implants Pty Ltd.Irene, South Africa
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 19, 2019
- Devices covered
- 49
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMPACT CONICAL ABUTMENT FOR INT. HEX, ANGLED
- COMPACT CONICAL ABUTMENT FOR INT. HEX, CUFF
- COMPACT CONICAL ABUTMENT FOR PROVATA
- COMPACT CONICAL ABUTMENT FOR PROVATA, ANGLED
- COSMETIC ABUTMENT FOR INT. HEX
- COSMETIC ABUTMENT FOR INT. HEX, ANGLED
- COVER SCREW FOR INT. HEX
- COVER SCREW FOR PROVATA
- CUSTOM ABUTMENT BASE FOR INT. HEX, ENGAGING
- CUSTOM ABUTMENT BASE FOR INT. HEX, NON-ENGAGING
- CUSTOM ABUTMENT BASE FOR INT. HEX, PLATFORM MATCH, ENGAGING
- EQUATOR OVERDENTURE ABUTMENT FOR INT. HEX, CUFF
- EQUATOR OVERDENTURE ABUTMENT FOR PROVATA
- GOLD ABUTMENT, ENGAGING, FOR INT. HEX
- GOLD ABUTMENT, NON-ENGAGING, FOR INT. HEX
- HEALING ABUTMENT FOR INT. HEX
- HEALING ABUTMENT FOR INT. HEX, PLATFORM MATCH
- HEALING ABUTMENT FOR PROVATA
- HEXED TITANIUM SCREW FOR INT. HEX
- HEXED TITANIUM SCREW FOR INT. HEX PASSIVE
- HEXED TITANIUM SCREW FOR INT. HEX, ANGLED ABUTMENT
- HEXED TITANIUM SCREW FOR PROVATA
- HEXED TITANIUM SCREW FOR PROVATA, ANGLE ABUTMENT
- HEXED TITANIUM SCREW FOR PROVATA, PASSIVE
- INTERNAL HEX 12 DEGREE CO-AXIS IMPLANT
- INTERNAL HEX MSC 12 DEGREE CO-AXIS IMPLANT
- INTERNAL HEX MSC TAPERED IMPLANT
- INTERNAL HEX TAPERED IMPLANT
- PASSIVE ABUTMENT FOR INT. HEX, ENGAGING
- PASSIVE ABUTMENT FOR INT. HEX, ENGAGING, PLATFORM MATCH
- PASSIVE ABUTMENT FOR INT. HEX, NON-ENGAGING
- PASSIVE ABUTMENT FOR PROVATA, ENGAGING
- PASSIVE ABUTMENT FOR PROVATA, NON-ENGAGING
- PROVATA
- PROVATA CO-AXIS
- QUAD GOLD SCREW FOR INT. HEX
- QUAD GOLD SCREW FOR INT. HEX PASSIVE
- SCANNING ABUTMENT FOR INT. HEX, ENGAGING
- SCANNING ABUTMENT FOR INT. HEX, NON-ENGAGING
- SCANNING FLAG / IMPRESSION COPING FOR PROVATA
- TITANIUM ABUTMENT BASE FOR INT. HEX
- TITANIUM ABUTMENT BASE FOR INT. HEX, COLLAR
- TITANIUM ABUTMENT BASE FOR INT. HEX, COLLAR, NON-ENGAGING
- TITANIUM ABUTMENT BASE FOR INT. HEX, NON-ENGAGING
- TITANIUM ABUTMENT BASE FOR INT. HEX, PLATFORM MATCH
- TITANIUM ABUTMENT FOR INT. HEX, ENGAGING
- TITANIUM ABUTMENT FOR INT. HEX, NON-ENGAGING
- TITANIUM ABUTMENT FOR PROVATA, ENGAGING
- TITANIUM ABUTMENT FOR PROVATA, NON-ENGAGING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.