Medical device licence · 107544 · Class 3
SIRONA BIOABUTMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 24, 2022. It is in Health Canada’s list of active licences.
- Licence number
- 107544
- Licence holder
- B.T.I. Biotechnology Institute S.L.Minano, Spain
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- March 24, 2022
- Devices covered
- 8
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INTERNA NARROW SIRONA BIOABUTMENT NON-ROTATING
- INTERNA NARROW SIRONA BIOABUTMENT ROTATING
- INTERNA UNIVERSAL SIRONA BIOABUTMENT LONG NON-ROTATING
- INTERNA UNIVERSAL SIRONA BIOABUTMENT ROTATING
- MULTI-IM UNIVERSAL SIRONA BIOABUTMENT
- UNIT NARROW SIRONA BIOABUTMENT
- UNIT UNIVERSAL SIRONA BIOABUTMENT
- UNIT WIDE SIRONA BIOABUTMENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.