Medical device licence · 95644 · Class 2
SIX MONTH SMILES SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed August 25, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 95644
- Licence holder
- Xplora Usa LlcCarrollton, TX, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- August 25, 2015
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIAMOND DISC
- FINISHING CARBIDE BUR
- SIX MONTH SMILES ARCH WIRES
- SIX MONTH SMILES BONDED RETAINER
- SIX MONTH SMILES CLEAR ELASTOMERICS
- SIX MONTH SMILES DIAMOND BURS
- SIX MONTH SMILES DIAMOND STRIPS
- SIX MONTH SMILES ELASTIC ATTACHERS
- SIX MONTH SMILES ESSIX REMOVABLE RETAINER
- SIX MONTH SMILES EYELETS/LINGUAL BUTTONS (METAL)
- SIX MONTH SMILES HAWLEY REMOVABLE RETAINER
- SIX MONTH SMILES INTERPROXIMAL REDUCATION STRIPS
- SIX MONTH SMILES INVISIBLE ALIGNERS
- SIX MONTH SMILES LIGHT CURE ADHESIVES
- SIX MONTH SMILES LUCID-LOK COMPOSITE BRACKET SET
- SIX MONTH SMILES LUCID-LOK COMPOSITE CLEARLETS
- SIX MONTH SMILES LUCID-LOK INDIVIDUAL BRACKETS
- SIX MONTH SMILES LUCID-LOK METAL MOLAR TUBES
- SIX MONTH SMILES LUCID-LOK STAINLESS STEEL LIGATURE TIES
- SIX MONTH SMILES LUCID-LOK TOOTH COLOR NITI OPEN COIL SPRINGS
- SIX MONTH SMILES RUBBER BANDS
- SIX MONTH SMILES STAINLESS STEEL RETAINER WIRE
- SIX MONTH SMILES WAX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.