Medical device licence · 113335 · Class 2
BIOSONIC SCALER INSERT
Yes: licensed in Canada
Licence status Issued (active); first licensed May 16, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 113335
- Licence holder
- Dent4You AgHeerbrugg, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 16, 2025
- Devices covered
- 16
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- US200 #10 SLIM OPTIMIST, 25KHZ
- US200 #10 SLIM OPTIMIST, 30KHZ
- US200 #10 SLIM SUPERSOFT OPTIMIST, 25KHZ
- US200 #10 SLIM SUPERSOFT OPTIMIST, 30KHZ
- US200 #10 SLIM SUPERSOFT, 25KHZ
- US200 #10 SLIM SUPERSOFT, 30KHZ
- US200 #10 SLIM, 25KHZ
- US200 #10 SLIM, 30KHZ
- US200 #10 UNIVERSAL OPTIMIST, 25KHZ
- US200 #10 UNIVERSAL OPTIMIST, 30KHZ
- US200 #10 UNIVERSAL SUPERSOFT, 25KHZ
- US200 #10 UNIVERSAL SUPERSOFT, 30KHZ
- US200 #10 UNIVERSAL, 25KHZ
- US200 #10 UNIVERSAL, 30KHZ
- US200 #1000 TRIPLE BEND, 25KHZ
- US200 #1000 TRIPLE BEND, 30KHZ
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.