Medical device licence · 90478 · Class 2
TMJ SPLINTS AND DEPROGRAMMERS
Yes: licensed in Canada
Licence status Issued (active); first licensed January 8, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 90478
- Licence holder
- Great Lakes Dental TechnologiesTonawanda, NY, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- January 8, 2013
- Devices covered
- 27
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- B" SPLINT/DAWSON ARCH"
- CRANHAM DEPROGRAMMER
- CUSTOM SPLINT APPLIANCE
- DAWSON DEPROGRAMMER
- DUAL ARCH SCRIBE DEPROGRAMMER
- ESSIX SPLINT
- FLAT PLANE SPLINT
- FULL CONTACT W/ANT GUIDANCE
- KOIS DEPROGRAMMER
- L.A.R.S. SPLINT
- MINI DEPROGTAMMER SPLINT
- MODIFIED FCTL DISTRACTION APPL
- MONGINI SPLINT
- OVERLAY SPLINT (ACR OCCLUSAL)
- OVERLAY/INVISIBLE RETAINER
- RHEA FLAT PLANE SPLINT
- RHEA FULL CONTACT W/ANT GUIDANCE
- RHEA WEAR GUARD
- SOFT FLAT PLANE SPLINT
- SOFT FULL CNTCT W/ANT GUIDANCE
- SPEAR ANTERIOR DEPROGRAMMER
- SPLINT
- SPLINT REMAKE
- SPLINT REPAIR
- SPLINT-FLAT PLANE
- SPLINT-PULL FORWARD ANT. REPO
- STABILIZATION/UCSF SPLINT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.