Medical device licence · 86459 · Class 3
GUTTA PERCHA POINTS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 28, 2011. It is in Health Canada’s list of active licences.
- Licence number
- 86459
- Licence holder
- Sure Dent CorporationSeongnam-Si, GD, South Korea
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 28, 2011
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- GUTTA PERCHA OBTURATOR
- GUTTA PERCHA POINTS (ACCESSORY SIZE)
- GUTTA PERCHA POINTS (PROTAPER) SIZE
- GUTTA PERCHA POINTS 4% (TAPER) SIZE
- GUTTA PERCHA POINTS 6% (TAPER) SIZE
- GUTTA PERCHA POINTS MM MARKED
- SURE-ENDO BIO GP POINTS (4% ISO SIZE)
- SURE-ENDO BIO GP POINTS (4% ISO SIZE, ENDO-AIDE)
- SURE-ENDO BIO GP POINTS (6% ISO SIZE)
- SURE-ENDO BIO GP POINTS (6% ISO SIZE, ENDO-AIDE)
- SURE-ENDO GUTTA PERCHA POINTS (2% ISO SIZE)
- SURE-ENDO GUTTA PERCHA POINTS (2% ISO SIZE, ENDO-AIDE)
- SURE-ENDO GUTTA PERCHA POINTS (2% ISO SIZE, VIAL)
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.