Medical device licence · 93381 · Class 3
INCLUSIVE TITANIUM SCREWS
Yes: licensed in Canada
Licence status Issued (active); first licensed June 12, 2014. It is in Health Canada’s list of active licences.
- Licence number
- 93381
- Licence holder
- Prismatik Dentalcraft, Inc.(A Wholly Owned Sub. Of Glidewell Lab.)Irvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Family
- First licensed
- June 12, 2014
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INCLUSIVE ANGLED MULTI-UNIT ABUTMENT SCREW COMPATIBLE WITH: BIOMET 3I CERTAIN
- INCLUSIVE ANGLED MULTI-UNIT ABUTMENT SCREW COMPATIBLE WITH: CAMLOG SCREW-LINE
- INCLUSIVE ANGLED MULTI-UNIT ABUTMENT SCREW COMPATIBLE WITH: DENTSPLY IMPLANTS ASTRA TECH IMPLANT SYSTEM
- INCLUSIVE ANGLED MULTI-UNIT ABUTMENT SCREW COMPATIBLE WITH: NOBEL BIOCARE BRANEMARK SYSTEM
- INCLUSIVE ANGLED MULTI-UNIT ABUTMENT SCREW COMPATIBLE WITH: NOBEL BIOCARE NOBELACTIVE
- INCLUSIVE ANGLED MULTI-UNIT ABUTMENT SCREW COMPATIBLE WITH: NOBEL BIOCARE NOBELREPLACE
- INCLUSIVE ANGLED MULTI-UNIT ABUTMENT SCREW COMPATIBLE WITH: STRAUMANN BONE LEVEL NC/RC
- INCLUSIVE MULTI-UNIT ABUTMENT SCREW, ANGLED
- INCLUSIVE MULTI-UNIT PROSTHETIC SCREW COMPATIBLE WITH: BIOMET 3I CERTAIN
- INCLUSIVE MULTI-UNIT PROSTHETIC SCREW COMPATIBLE WITH: STRAUMANN BONE LEVEL
- INCLUSIVE PROSTHETIC SCREW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.