ApprovalTrail

Medical device licence · 27743 · Class 3

RESTORATIVE COMPOSITE MATERIAL

Yes: licensed in Canada

Licence status Issued (active); first licensed February 28, 2001. It is in Health Canada’s list of active licences.
Licence number
27743
Licence holder
Bisco, Inc.Schaumburg, Illinois, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Group Family
First licensed
February 28, 2001
Devices covered
18

Devices on this licence

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

  • AELITE AESTHETIC ENAMEL
  • AELITE ALL-PURPOSE BODY
  • AELITE LS PACKABLE DENTIN
  • AELITE LS PACKABLE ENAMEL
  • AELITEFLO MICROHYBRID COMPOSITE
  • BIS-CORE CORE MATERIAL
  • BISFIL 2B SELF CURE COMPOSITE
  • CORE-FLO DC LITE NATURAL A1 DUAL-SYRINGE
  • CORE-FLO DC LITE NATURAL A1 DUAL-SYRINGE PACKAGE
  • CORE-FLO DC LITE OPAQUE WHITE DUAL-SYRINGE
  • CORE-FLO DC LITE OPAQUE WHITE DUAL-SYRINGE PACKAGE
  • CORE-FLO DC NATURAL DUAL-SYRINGE
  • CORE-FLO DC NATURAL DUAL-SYRINGE PACKAGE
  • CORE-FLO DC OPAQUE WHITE DUAL-SYRINGE
  • CORE-FLO DC OPAQUE WHITE DUAL-SYRINGE PACKAGE
  • LIGHT CORE CORE BUILD-UP COMPOSITE
  • REVEAL LIGHT-CURED BONDED FUNCTIONAL ESTHETIC PROTOTYPE
  • TESCERA CHAR COMPOSITE

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