Gojan-Dong, Namdong-Gu, KR · 12 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EMA | Cement, Dental | Class II | Dental | 3 | 2026-09-25 |
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 3 | 2026-09-21 |
| KIF | Resin, Root Canal Filling | Class II | Dental | 2 | 2026-09-11 |
| KLE | Agent, Tooth Bonding, Resin | Class II | Dental | 2 | 2024-11-01 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | Class II | Dental | 1 | 2026-07-02 |
| EBG | Crown And Bridge, Temporary, Resin | Class II | Dental | 1 | 2022-03-10 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-25 | K262983 | EsTemp Implant | EMA | Class II | Dental |
| 2026-09-21 | K262982 | Core·it Dual | EBF | Class II | Dental |
| 2026-09-11 | K262050 | Vioseal X | KIF | Class II | Dental |
| 2026-07-02 | K261129 | OrthoFit | DYH | Class II | Dental |
| 2025-06-20 | K250566 | EsCem RMGI | EMA | Class II | Dental |
| 2025-05-30 | K250317 | EsFlow PLUS | EBF | Class II | Dental |
| 2024-11-07 | K242702 | VioSeal | KIF | Class II | Dental |
| 2024-11-01 | K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | KLE | Class II | Dental |
| 2024-07-22 | K241445 | K-Bond Universal | KLE | Class II | Dental |
| 2023-07-24 | K231523 | EsCom250 | EBF | Class II | Dental |
| 2022-12-19 | K214076 | EsCem | EMA | Class II | Dental |
| 2022-03-10 | K214071 | Hexa-Temp | EBG | Class II | Dental |