ApprovalTrail

Medical device licence · 65537 · Class 3

GRADIA LIGHT CURED COMPOSITE

Yes: licensed in Canada

Licence status Issued (active); first licensed August 19, 2004. It is in Health Canada’s list of active licences.
Licence number
65537
Licence holder
GC America Inc.Alsip, Illinois, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
August 19, 2004
Devices covered
21

Devices on this licence

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

  • FOUNDATION OPAQUE REFILL PACKAGE
  • GRADIA CERVICAL TRANSLUCENT REFILL PACKAGE
  • GRADIA DENTIN REFILL PACKAGE
  • GRADIA DENTIN SHADES
  • GRADIA ENAMEL INTENSIVE SHADES
  • GRADIA ENAMEL REFILL PACKAGE
  • GRADIA ENAMEL SHADES
  • GRADIA FLOWABLE COMPOSITE SHADES
  • GRADIA INTENSIVE COLOR REFILL PACKAGE
  • GRADIA INTENSIVE COLOR SET
  • GRADIA MASTER SET PACKAGE
  • GRADIA OPAQUE REFILL PACKAGE
  • GRADIA OPAQUE WHITE SHADES
  • GRADIA OPAQUS DENTIN INTENSIVE REFILL PACKAGE
  • GRADIA OPAQUS DENTIN REFILL PACKAGE
  • GRADIA OPAQUS DENTIN SHADES
  • GRADIA PACKAGE REFILLS
  • GRADIA SHOULDER DENTIN REFILL PACKAGE
  • GRADIA STANDARD SET PACKAGE
  • GRADIA TRANSLUCENT REFILL PACKAGE
  • MARGIN OPAQUE REFILL PACKAGE

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