Daejeon, KR · 17 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | 7 | 2025-07-23 |
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | 6 | 2024-11-25 |
| EIH | Powder, Porcelain | Class II | Dental | 2 | 2025-07-10 |
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 1 | 2024-09-11 |
| EBG | Crown And Bridge, Temporary, Resin | Class II | Dental | 1 | 2021-12-08 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-07-23 | K250280 | SD TL Implant System | DZE | Class II | Dental |
| 2025-07-10 | K250063 | ARENA Star, Galaxy Star | EIH | Class II | Dental |
| 2025-02-24 | K241703 | SD Implant System | DZE | Class II | Dental |
| 2025-01-06 | K242753 | SD TL Implant System | DZE | Class II | Dental |
| 2024-11-25 | K242245 | Customized Abutment | NHA | Class II | Dental |
| 2024-09-11 | K232559 | C&B NFH Hybrid | EBF | Class II | Dental |
| 2024-06-05 | K240603 | Ti-Base & Master Fix | NHA | Class II | Dental |
| 2024-05-09 | K234112 | Customized Abutment | NHA | Class II | Dental |
| 2024-04-26 | K240091 | NB Mini Implant System | DZE | Class II | Dental |
| 2023-12-19 | K232560 | Angled Abutment | NHA | Class II | Dental |
| 2023-07-01 | K230725 | NB Implant System | DZE | Class II | Dental |
| 2023-04-28 | K223634 | Customized Abutment | NHA | Class II | Dental |
| 2023-02-27 | K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | EIH | Class II | Dental |
| 2022-09-19 | K222131 | NB 1 SA Implant System | DZE | Class II | Dental |
| 2022-04-06 | K213506 | NB 1 SA Implant System | DZE | Class II | Dental |
| 2021-12-08 | K210817 | C&B 5.0 Hybrid | EBG | Class II | Dental |
| 2020-03-09 | K193425 | Pre-Milled Blank | NHA | Class II | Dental |