Arum Dentistry Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 17
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K250280 | SD TL Implant System | July 23, 2025 |
| K250063 | ARENA Star, Galaxy Star | July 10, 2025 |
| K241703 | SD Implant System | February 24, 2025 |
| K242753 | SD TL Implant System | January 6, 2025 |
| K242245 | Customized Abutment | November 25, 2024 |
| K232559 | C&B NFH Hybrid | September 11, 2024 |
| K240603 | Ti-Base & Master Fix | June 5, 2024 |
| K234112 | Customized Abutment | May 9, 2024 |
| K240091 | NB Mini Implant System | April 26, 2024 |
| K232560 | Angled Abutment | December 19, 2023 |
| K230725 | NB Implant System | July 1, 2023 |
| K223634 | Customized Abutment | April 28, 2023 |
| K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | February 27, 2023 |
| K222131 | NB 1 SA Implant System | September 19, 2022 |
| K213506 | NB 1 SA Implant System | April 6, 2022 |
| K210817 | C&B 5.0 Hybrid | December 8, 2021 |
| K193425 | Pre-Milled Blank | March 9, 2020 |