Cheongju-Si, KR · 19 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Class II | Dental | 5 | 2026-06-02 |
| KLE | Agent, Tooth Bonding, Resin | Class II | Dental | 4 | 2022-06-15 |
| KIF | — | — | — | 4 | 2021-03-25 |
| EMA | Cement, Dental | Class II | Dental | 2 | 2026-07-09 |
| EBG | Crown And Bridge, Temporary, Resin | Class II | Dental | 2 | 2020-02-13 |
| ELW | Material, Impression | Class II | Dental | 1 | 2026-03-19 |
| EBZ | Activator, Ultraviolet, For Polymerization | Class II | Dental | 1 | 2020-08-07 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-09 | K261166 | DIA-CEM | EMA | Class II | Dental |
| 2026-06-02 | K261093 | DIAFIL | EBF | Class II | Dental |
| 2026-05-19 | K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | EBF | Class II | Dental |
| 2026-03-19 | K254112 | Dia-X Sil Bite | ELW | Class II | Dental |
| 2023-07-28 | K231552 | Dia-Cem | EMA | Class II | Dental |
| 2022-06-15 | K220804 | Dia-X Bond Universal | KLE | Class II | Dental |
| 2022-01-31 | K213401 | DIAPLUS Universal | KLE | Class II | Dental |
| 2021-06-28 | K210421 | Diafil & Diafil Capsule | EBF | Class II | Dental |
| 2021-03-25 | K210333 | DiaPaste | KIF | — | — |
| 2020-09-18 | K200174 | DIA-ROOT BIO MTA | KIF | — | — |
| 2020-08-07 | K200809 | D-LUX+ | EBZ | Class II | Dental |
| 2020-06-25 | K200175 | DIA-ROOT BIO Sealer | KIF | — | — |
| 2020-05-26 | K192392 | DiaPlus | KLE | Class II | Dental |
| 2020-03-27 | K190091 | Diapaste | KIF | — | — |
| 2020-03-25 | K192284 | DiaFil Flow | EBF | Class II | Dental |
| 2020-03-20 | K192510 | DIAFIL & DIAFIL Capsule | EBF | Class II | Dental |
| 2020-02-13 | K192158 | DiaTemp | EBG | Class II | Dental |
| 2020-02-13 | K192022 | DiaTemp Flow | EBG | Class II | Dental |
| 2020-02-07 | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit | KLE | Class II | Dental |