Medical device licence · 64340 · Class 2
NITANIUM ORTHODONTIC WIRES
Yes: licensed in Canada
Licence status Issued (active); first licensed May 11, 2004. It is in Health Canada’s list of active licences.
- Licence number
- 64340
- Licence holder
- Ortho Organizers Inc.Savannah, GA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- May 11, 2004
- Devices covered
- 80
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ADVANCED ARCHWIRE
- AUTHENTIC NITINOL
- BETA III
- BETA III INTERNATIONAL
- BIO-KINETIX NITANIUM OVAL
- BIO-KINETIX NITANIUM RCS
- BIO-KINETIX PLUS
- BIO-KINETIX THERMAL
- BIO-KINETIX THERMAL NITANIUM
- BRASS SEPARATING RING
- CLASSONE REGENCY BLACK DIAMON INTERNATIONAL DIMPLED ARCHWIRES
- CLOSED COIL SPRING
- CNA BETA III
- CONFIDENTIAL A-FORM
- CONFIDENTIAL NATURAL
- CONFIDENTIAL REVERSE CURVE
- CV SUPER FORCE
- D-LX BIO-KINETIX PLUS
- DISTAL COIL SPRING
- DRIFT-FREE ELASTINOL
- ECONO NICKEL TITANIUM
- ELASTINOL
- ELASTINOL ARCHWIRE
- INTRUSION ARCH
- LOWER BRAID 8 NITANIUM
- LOWER DIMPLED PRO FORM ACCEL LOW FRICTION THERMAL NITANIUM
- LOWER PF BIO-KINETIX THERMAL NITANIUM
- NITANIUM
- NITANIUM RCS
- NITANIUM SPRING
- NITANIUM TORQUED ARCHWIRE
- NT OVAL ARCH
- ONYX ULTRA NATURAL DRIFT FREE
- PEAK SEPARATING SPRING
- PERM-A-FORCE SPRING
- PRO FORM NITI
- PROFORM NITANIUM TORQUE
- RCS SUPER ELASTIC NITANIUM WIRE
- REGENCY
- REGENCY A FORM
- REGENCY BLACK DIAMOND A FORM DIMPLED
- REGENCY BLACK DIAMOND NATURAL DIMPLED
- REGENCY BLACK DIAMOND NOMAD DIMPLED
- REGENCY INTRUSION
- REGENCY MULTI 3 NATURAL
- REGENCY MULTI-MODULUS
- REGENCY NATURAL
- REGENCY NOMAD
- REGENCY OPTITHERM NATURAL
- REGENCY OPTITHERM NATURAL DIMPLED
- REGENCY OPTITHERM NOMAD
- REGENCY REVERSE CURVE STRAIGHT LEG
- REGENCY SEPARATING SPRING
- REGENCY SPOOL
- REGENCY STANDARD
- REGENCY STRAIGHT
- REGENCY T2
- REGENCY THERM RIBBON
- REGENCY THERMAL RIBBON
- REGENCY ULTRA THERM NATURAL DIMPLED
- REGENCY ULTRATHERM
- REGENCY ULTRATHERM A FORM
- REGENCY ULTRATHERM A FORM DIMPLED
- REGENCY ULTRATHERM NATURAL
- REGENCY ULTRATHERM NOMAD
- REGENCY ULTRATHERM NOMAD DIMPLED
- RETRO-ARCH
- SPOOLED ELASTINOL
- SPOOLED NITANIUM
- SPRING
- THERM-A-FORM
- TRI-FORCE THERMAL
- UPPER BRAID 8 NITANIUM
- UPPER DIMPLED PRO FORM ACCEL LOW FRICTION THERMAL NITANIUM
- UTILITY ARCH
- VALUE NITI
- VARIABLE COIL SPRING
- VARIABLE FORCE 3
- VARIABLE FORCE NITANIUM SPRING
- VARIABLE FORCE SPRING
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “nitanium”. A notice may cover another product or only some lots: read it to see what it covers.
- Spooled Nitanium WireNovember 9, 2016 · Medical devices · Type III
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.