ApprovalTrail

Medical device licence · 11450 · Class 3

HEALING ABUTMENTS - TITANIUM

Yes: licensed in Canada

Licence status Issued (active); first licensed September 7, 1999. It is in Health Canada’s list of active licences.
Licence number
11450
Licence holder
Zimvie Us Corp Llc.Palm Beach Gardens, FL, United States
Risk class
Class III (moderate to high risk)
Licence type
Device Family
First licensed
September 7, 1999
Devices covered
28

Devices on this licence

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

  • CERTAIN BELLATEK ENCODE EMERGENCE HEALING ABUTMENT
  • CERTAIN ENCODE 2-PC EP HEALING ABUTMENT
  • CERTAIN EP HEALING ABUTMENT
  • CERTAIN GINGIHUE ABUTMENTS - TEMP
  • CERTAIN GINGIHUE POST (ABUTMENT)
  • CERTAIN HEALING ABUTMENT
  • CONICAL EP TEMP CYLINDER
  • CONICAL TEMP CYLINDER
  • DISTAL EXTENTION
  • ENCODE 2-PC EP HEALING ABUTMENT
  • EP HEALING ABUTMENT
  • EZTETIC BELLATEK ENCODE EMERGENCE HEALING ABUTMENT
  • GINGIHUE POSTS - TEMP
  • HEALING ABUTMENTS
  • IOL TEMPORARY CYLINDER
  • MICROMINI CONICAL TEMP CYLINDER
  • MICROMINI GINGIHUE POST
  • MICROMINIMPLANT CONICAL TEMP CYLINDER
  • MICROMINIPLAN HEALING ABUTMENT
  • ONE-PIECE CERTAIN MICROMINIPLANT HEALING ABUTMENT
  • ONE-PIECE HEALING ABUTMENTS
  • TEMP HEALING RETENTION CYLINDER
  • TEMPORARY CYLINDER (STANDARD ABUTMENT)
  • TSV BELLATEK ENCODE EMERGENCE HEALING ABUTMENT
  • TSV BELLATEK ENCODE HEALING ABUTMENT
  • WIDE DIAMETER 5.0MM EP ONE-PIECE HEALING ABUTMENT
  • WIDE DIAMETER 6.0MM EP ONE-PIECE HEALING ABUTMENT
  • WIDE DIAMETER ONE-PIECE CERTAIN HEALING ABUTMENT

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