ApprovalTrail

Medical device licence · 4322 · Class 3

DENTAL COMPOSITE

Yes: licensed in Canada

Licence status Issued (active); first licensed June 4, 1999. It is in Health Canada’s list of active licences.
Licence number
4322
Licence holder
Kerr CorporationOrange, California, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
June 4, 1999
Devices covered
27

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • HERCULITE ULTRA AMBER - SYRINGE
  • HERCULITE ULTRA AMBER - UNIDOSE
  • HERCULITE ULTRA DENTIN - SYRINGE
  • HERCULITE ULTRA DENTIN - UNIDOSE
  • HERCULITE ULTRA ENAMEL - SYRINGE
  • HERCULITE ULTRA ENAMEL - UNIDOSE
  • HERCULITE ULTRA FLOW
  • HERCULITE ULTRA LIGHT INCISAL - SYRINGE
  • HERCULITE ULTRA LIGHT INCISAL - UNIDOSE
  • HERCULITE ULTRA XL - SYRINGE
  • HERCULITE ULTRA XL - UNIDOSE
  • POINT 4
  • PREMISE
  • PREMISE FLOWABLE ASSORTMENT
  • PREMISE FLOWABLE SHADES
  • PREMISE FLOWABLE UNIVERSAL OPAQUE
  • PREMISE SYRINGE
  • PREMISE SYRINGE OPAQUE
  • PREMISE SYRINGE TRANSLUCENT
  • PREMISE UNIDOSE
  • PREMISE UNIDOSE OPAQUE
  • PREMISE UNIDOSE TRANSLUCENT
  • PRODIGY
  • PRODIGY CONDENSABLE
  • REVOLUTION FORMULA 2
  • XRV HERCULITE
  • XRV HERCULITE UNIDOSE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.