Dong-Gu, KR · 6 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | Class I | Dental | 3 | 2025-07-18 |
| EKX | Handpiece, Direct Drive, Ac-Powered | Class I | Dental | 1 | 2023-11-09 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Class I | Dental | 1 | 2022-07-29 |
| EFA | — | — | — | 1 | 2020-08-25 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-07-18 | K231562 | ELEC ENGINE (Model: ISE-170L) | EBW | Class I | Dental |
| 2023-11-09 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | EKX | Class I | Dental |
| 2022-07-29 | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | EGS | Class I | Dental |
| 2022-02-07 | K201191 | ELEC-LED | EBW | Class I | Dental |
| 2021-05-21 | K201192 | Impla-NX (Model: ISE-270M) | EBW | Class I | Dental |
| 2020-08-25 | K192809 | Dental Handpiece | EFA | — | — |