Medical device licence · 97811 · Class 3
ON1 CONCEPT
Yes: licensed in Canada
Licence status Issued (active); first licensed October 21, 2016. It is in Health Canada’s list of active licences.
- Licence number
- 97811
- Licence holder
- Nobel Biocare AbGoteborg, Sweden
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 21, 2016
- Devices covered
- 28
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ON1 BASE CC NP
- ON1 BASE CC RP
- ON1 BASE CC WP
- ON1 BASE XEAL CONICAL CONNECTION NP
- ON1 BASE XEAL CONICAL CONNECTION RP
- ON1 BASE XEAL CONICAL CONNECTION WP
- ON1 CLINICAL SCREW NP
- ON1 CLINICAL SCREW RP
- ON1 CLINICAL SCREW WP
- ON1 ESTHETIC ABUTMENT TITANIUM NP
- ON1 ESTHETIC ABUTMENT TITANIUM RP
- ON1 ESTHETIC ABUTMENT TITANIUM WP
- ON1 HEALING CAP NP
- ON1 HEALING CAP RP
- ON1 HEALING CAP WP
- ON1 IOS HEALING CAP NP
- ON1 IOS HEALING CAP RP
- ON1 IOS HEALING CAP WP
- ON1 PROSTHETIC SCREW NP/RP/WP
- ON1 TEMPORARY ABUTMENT NP
- ON1 TEMPORARY ABUTMENT RP
- ON1 TEMPORARY ABUTMENT WP
- ON1 UNIVERSAL ABUTMENT NON-ENGAGING NP
- ON1 UNIVERSAL ABUTMENT NON-ENGAGING RP
- ON1 UNIVERSAL ABUTMENT NON-ENGAGING WP
- ON1 UNIVERSAL ABUTMENT NP
- ON1 UNIVERSAL ABUTMENT RP
- ON1 UNIVERSAL ABUTMENT WP
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.