| Proprietary Name: |
Cover Screw Headless; Cover Screw Implant; Full OSSEOTITE Implant; Full OSSEOTITE Tapered Implant; Full OSSEOTITE XP Miniplant; Implant Cover Screw; LTX Implant; LTX XP Miniplant; NanoTite Implant; NanoTite Tapered Implant; OSSEOTITE Implant; OSSEOTITE Tapered Implant; OSSEOTITE XP Implant; OSSEOTITE XP Miniplant |
| Classification Name: |
IMPLANT, ENDOSSEOUS, ROOT-FORM |
| Product Code: |
DZE |
| Device Class: |
2 |
| Regulation Number: |
872.3640 |
| Medical Specialty: |
Dental |
| Registered Establishment Name: |
ZimVie Canada Inc.
|
| Registered Establishment Number: |
1000244346
|
| Premarket Submission Number: |
K063286 |
| Owner/Operator: |
ZimVie US Corp LLC |
| Owner/Operator Number: |
1038806
|
| Establishment Operations: |
Foreign Exporter
|