Medical device licence · 89829 · Class 3
INSYNC SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed October 9, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89829
- Licence holder
- Jensen Industries, IncorporatedNorth Haven, CT, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 9, 2012
- Devices covered
- 25
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INSYNC SYSTEM - (MONOCAST) INGOT
- INSYNC SYSTEM - DENTIN INGOT
- INSYNC SYSTEM - GLAZE LIQUID
- INSYNC SYSTEM - INGOT
- INSYNC SYSTEM - LIQUID
- INSYNC SYSTEM - MODELING LIQUID
- INSYNC SYSTEM - OPAQUE LIQUID
- INSYNC SYSTEM - TI OPAQUE POWDER
- INSYNC SYSTEM - ZR LINER
- INSYNC SYSTEM - ZRTI CHROMA MODIFIER
- INSYNC SYSTEM - ZRTI CLEAR
- INSYNC SYSTEM - ZRTI CORRECTION
- INSYNC SYSTEM - ZRTI DENTINE
- INSYNC SYSTEM - ZRTI ENAMEL
- INSYNC SYSTEM - ZRTI GINGIVAL
- INSYNC SYSTEM - ZRTI GLAZE
- INSYNC SYSTEM - ZRTI MARGIN
- INSYNC SYSTEM - ZRTI MODIFIER
- INSYNC SYSTEM - ZRTI MOLAR ENAMEL
- INSYNC SYSTEM - ZRTI NECK TRANSPA
- INSYNC SYSTEM - ZRTI NEUTRAL
- INSYNC SYSTEM - ZRTI OPAK DENTINE
- INSYNC SYSTEM - ZRTI OPAL
- INSYNC SYSTEM - ZRTI OPAQUE DENTIN
- INSYNC SYSTEM - ZRTI TRANSLUCENT
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “insync”. A notice may cover another product or only some lots: read it to see what it covers.
- INSYNC III ATRIAL SYNCHRONOUS BIVENTRICULAR PACING DEVICE (2015-11-09)November 9, 2015 · Medical devices · Health products · Type I
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.