Medical device licence · 110717 · Class 3
DIRECTARCH
Yes: licensed in Canada
Licence status Issued (active); first licensed January 22, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 110717
- Licence holder
- Implant Direct Sybron Manufacturing LlcThousand Oaks, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 22, 2024
- Devices covered
- 13
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- DIRECTARCH CYLINDER - 4.5MM-GOLD
- DIRECTARCH CYLINDER - 6.0MM
- DIRECTARCH CYLINDER BALL LAB SCREW (5PK)
- DIRECTARCH DIRECT TO MUA SCREW (10PK)
- DIRECTARCH HEALING COLLAR
- DIRECTARCH TEMP ABUTMENT REPLACEMENT SCREW (5PK)
- DIRECTARCH TEMPORARY ABUTMENT
- LEGACY DIRECTARCH MUA REPLACEMENT SCREW
- LEGACY DIRECTARCH PLATFORM MUA COLLAR
- LEGACY DIRECTARCH PLATFORM STRAIGHT MUA COLLAR
- SIMPLY ICONIC/INTERACTIVE DIRECTARCH PLATFORM MUA COLLAR
- SIMPLY ICONIC/INTERACTIVE DIRECTARCH PLATFORM STRAIGHT MUA COLLAR
- SIMPLY ICONIC/INTERACTIVE DIRECTARCH REPLACEMENT SCREW
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.