Medical device licence · 73847 · Class 3
SCREWINDIRECT IMPLANT SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed April 26, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 73847
- Licence holder
- Implant Direct Sybron Manufacturing LlcThousand Oaks, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- April 26, 2007
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- SCREWINDIRECT SYSTEM - GOLD OVERDENTURE ABUTMENT COPING
- SCREWINDIRECT SYSTEM - GOLD/PLASTIC OVERDENTURE ABUTMENT COPING
- SCREWINDIRECT SYSTEM - IMPLANT
- SCREWINDIRECT SYSTEM - PLASTIC OVERDENTURE ABUTMENT COPING
- SCREWINDIRECT SYSTEM - TITANIUM OVERDENTURE ABUTMENT COPING
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.