Medical device licence · 109304 · Class 2
DELIVERY SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed May 3, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109304
- Licence holder
- Engle Dental Systems, LlcHillsboro, OR, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 3, 2023
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AS-1 POST DELIVERY SYSTEM
- AS1 360 DELIVERY SYSTEM
- E120 HYGIENE DELIVERY SYSTEM
- E1200 AS1 DELIVERY SYSTEM
- E200 AS1 DELIVERY SYSTEM
- E220 HYGIENE DELIVERY SYSTEM
- E2200 DELIVERY SYSTEM SYSTEM
- E300 360 DELIVERY SYSTEM
- E300 HYGIENE DELIVERY SYSTEM
- E300 POST DELIVERY SYSTEM
- E310 OTP CUSPIDOR DELIVERY SYSTEM
- E320 OTP DELIVERY SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.