NOBEL BIOCARE SERVICES AG
FDA Regulatory Profile
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2828-2020 | Class II | NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are inten | July 20, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K231219 | NobelZygoma PureSet Tray | June 27, 2023 |
| K220339 | Esthetic Abutments Nobel Biocare N1 | September 16, 2022 |
| K220048 | NobelProcera Zirconia N1 Base | July 29, 2022 |
| K211109 | N1 TiUltra TCC Implant System | December 21, 2021 |
| K212932 | Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray | December 18, 2021 |