Medical device licence · 82988 · Class 3
INTERNAL CONNECTION ABUTMENTS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 8, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 82988
- Licence holder
- Biohorizons Implant Systems Inc.Birmingham, AL, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 8, 2010
- Devices covered
- 37
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- 3.0MM SMARTSHAPE HEALER, ANTERIOR
- 3.0MM SMARTSHAPE HEALER, ANTERIOR, TALL
- 3.0MM SMARTSHAPE HEALER, MID
- 3.0MM SMARTSHAPE HEALER, MID, TALL
- 3.5MM SMARTSHAPE HEALER, ANTERIOR
- 3.5MM SMARTSHAPE HEALER, ANTERIOR, TALL
- 3.5MM SMARTSHAPE HEALER, MID
- 3.5MM SMARTSHAPE HEALER, MID, TALL
- 3.5MM SMARTSHAPE HEALER, POSTERIOR
- 3.5MM SMARTSHAPE HEALER, POSTERIOR, TALL
- 3INONE ABUTMENT (REG EMERGENCE)
- 4.5MM SMARTSHAPE HEALER, MID
- 4.5MM SMARTSHAPE HEALER, MID, TALL
- 4.5MM SMARTSHAPE HEALER, POSTERIOR
- 4.5MM SMARTSHAPE HEALER, POSTERIOR, TALL
- 5.7MM SMARTSHAPE HEALER, POSTERIOR
- 5.7MM SMARTSHAPE HEALER, POSTERIOR, TALL
- ABUTMENT WITH SCREW, COLLAR
- ANGLED ABUTMENT (REG EMERGENCE)
- ANGLED ABUTMENT WITH SCREW
- ANGLED ESTHETIC ABUTMENT (WIDE EMERGENCE)
- BALL ABUTMENT, COLLAR
- CUSTOM CAST ABUTMENT, HEXED
- CUSTOM CAST ABUTMENT, NON-HEXED
- EASY TI TEMP ABUTMENT, HEXED, LASER-LOK
- INSTANT FIXED OVERDENTURE ABUTMENT
- INTERNAL LASER-LOK HEALING ABUTMENT
- INTERNAL SIMP SOL ABUTMENT, LASER-LOK
- INTERNAL TITANIUM TEMPORARY ABUTMENT, HEXED
- INTERNAL TITANIUM TEMPORARY ABUTMENT, NON-HEXED
- NARROW EMERGENCE ABUTMENT
- NARROW HEALING ABUTMENT
- PLASTIC TEMPORARY ABUTMENT (REG EMERGENCE)
- REGULAR HEALING ABUTMENT
- STRAIGHT ESTHETIC ABUTMENT (REG EMERGENCE)
- STRAIGHT ESTHETIC ABUTMENT (WIDE EMERGENCE)
- WIDE HEALING ABUTMENT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.