Siheung-Si, KR · 13 510(k) clearances · 3 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | Class II | Dental | 4 | 2026-03-04 |
| EIH | Powder, Porcelain | Class II | Dental | 2 | 2024-11-20 |
| OAS | X-Ray, Tomography, Computed, Dental | Class II | Radiology | 2 | 2024-09-06 |
| ELW | Material, Impression | Class II | Dental | 2 | 2021-03-18 |
| DZL | Screw, Fixation, Intraosseous | Class II | Dental | 1 | 2025-08-13 |
| EHD | — | — | — | 1 | 2023-11-28 |
| DZE | Implant, Endosseous, Root-Form | Class II | Dental | 1 | 2023-09-23 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-08-26 | Class II | Ongoing | Z-0315-2026 | Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. | — | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a requir… |
| 2025-08-26 | Class II | Ongoing | Z-0314-2026 | Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. | — | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a requir… |
| 2025-08-26 | Class II | Ongoing | Z-0313-2026 | Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. | — | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a requir… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-03-04 | K251434 | Healing Abutment System | NHA | Class II | Dental |
| 2025-08-13 | K251569 | Bone Screw | DZL | Class II | Dental |
| 2024-11-20 | K242521 | Estar-ZE | EIH | Class II | Dental |
| 2024-09-06 | K233806 | T2 Plus | OAS | Class II | Radiology |
| 2024-02-20 | K233194 | TS Abutment System | NHA | Class II | Dental |
| 2023-12-05 | K232220 | SS Abutment System | NHA | Class II | Dental |
| 2023-11-28 | K232012 | N1 | EHD | — | — |
| 2023-09-23 | K222778 | Osstem Implant System | DZE | Class II | Dental |
| 2022-09-08 | K221684 | Osstem Abutment System | NHA | Class II | Dental |
| 2021-09-21 | K212303 | T2 | OAS | Class II | Radiology |
| 2021-07-02 | K210097 | Estar-Z | EIH | Class II | Dental |
| 2021-03-18 | K210041 | HySil Plus Impression Materials | ELW | Class II | Dental |
| 2020-01-30 | K192941 | HySil Super Fast Impression Materials | ELW | Class II | Dental |