OSSTEM Implant Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 68
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0314-2026 | Class II | Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. | August 26, 2025 |
| Z-0315-2026 | Class II | Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P. | August 26, 2025 |
| Z-0313-2026 | Class II | Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS. | August 26, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251434 | Healing Abutment System | March 4, 2026 |
| K251569 | Bone Screw | August 13, 2025 |
| K242521 | Estar-ZE | November 20, 2024 |
| K233806 | T2 Plus | September 6, 2024 |
| K233194 | TS Abutment System | February 20, 2024 |
| K232220 | SS Abutment System | December 5, 2023 |
| K232012 | N1 | November 28, 2023 |
| K222778 | Osstem Implant System | September 23, 2023 |
| K221684 | Osstem Abutment System | September 8, 2022 |
| K212303 | T2 | September 21, 2021 |
| K210097 | Estar-Z | July 2, 2021 |
| K210041 | HySil Plus Impression Materials | March 18, 2021 |
| K192941 | HySil Super Fast Impression Materials | January 30, 2020 |
| K183347 | K3 | September 4, 2019 |
| K183475 | T1-CS, T1-C | August 30, 2019 |
| K182881 | Bone Screw, Bone Tack | August 9, 2019 |
| K182091 | Osstem Abutment System | July 12, 2019 |
| K181854 | OssBuilder System | May 7, 2019 |
| K181236 | HySil Impression Materials | September 13, 2018 |
| K172354 | OssBuilder System | March 26, 2018 |