ApprovalTrail

Medical device licence · 106522 · Class 3

ALPHATECH IMPLANT SYSTEM

No longer licensed: cancelled: renewal not answered

Licence status Cancelled: renewal not answered; first licensed August 18, 2021; ended December 9, 2025. It is in Health Canada’s archive of licences no longer in force.
Licence number
106522
Licence holder
Fmz GmbhRostock, 13, Germany
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
August 18, 2021
Ended
December 9, 2025
Devices covered
51

Devices on this licence

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

  • 2.0 MM-DRILL
  • 2.8 MM-DRILL
  • ABUTMENT SCREW
  • ALPHA-LOC ABUTMENT
  • ANGLED ABUTMENT
  • ANGLED ABUTMENT P-SWITCH
  • BALL ABUTMENT
  • BALL ABUTMENT WITH CAP SET
  • BAR ABUTMENT
  • CAP DIRECT (POM) INCLUSIVE SCREWING
  • CAP DIRECT (TITANIUM) INCLUSIVE SCREWING
  • CAP INDIRECT (POM) INCLUSIVE SCREWING + ADHESIVE BASE
  • CAP INDIRECT (TITANIUM) INCLUSIVE SCREWING + ADHESIVE BASE
  • CERAMIC ABUTMENT
  • CORTICALIS-DRILL
  • COVER SCREW TL
  • COVER SCREWS
  • DRILL GS
  • FINISHER
  • FINISHER GS
  • FINISHER LONG
  • GINGIVA FORMER ABUTMENT
  • GINGIVA FORMER EMERGENZ-PROFILE
  • IMPLANTS TUBE-LINE BONITEX
  • IMPLANTS TUBE-LINE BONITEX P
  • IMPLANTS TUBE-LINE DUOTEX
  • IMPLANTS TUBE-LINE DUOTEX P
  • IMPLANTS TUBE-LINE PU BONITEX
  • IMPLANTS TUBE-LINE PU BONITEX P
  • IMPLANTS TUBE-LINE PU DUOTEX
  • IMPLANTS TUBE-LINE PU DUOTEX P
  • LOCATOR ABUTMENT
  • LOCATOR LABOR SET
  • LOCATOR RETENTION CAP
  • MUCOSA PUNCH
  • MULTI ABUTMENT PRAFAB
  • NYLON ELASTIC CAP
  • OP TRAY GUIDED SURGERY
  • OP-TRAY COMPLETE
  • PROVISONIAL ABUTMENT
  • ROUND DRILL
  • STANDARD ABUTMENT
  • STANDARD P-SWITCH ABUTMENT
  • TELESCOPIC ABUTMENT
  • TITANIUM BASE FOR SIRONA INLAB SYSTEM
  • TITANIUM BASE FOR ZIRCONIUM ABUTMENT
  • TITANIUM HOUSING
  • TREPHINE BUR
  • UNIVERSAL DRILL GS
  • UNIVERSAL DRILL-2 RING
  • UNIVERSAL DRILL-3 RING

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