Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Arum Dentistry Co., Ltd. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
265 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-07-23 | 173 | 0 |
| K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | 2025-07-10 | 181 | 0 |
| K241703 | SD Implant System | Arum Dentistry Co., Ltd. | 2025-02-24 | 256 | 0 |
| K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025-01-06 | 116 | 0 |
| K242245 | Customized Abutment | Arum Dentistry Co., Ltd. | 2024-11-25 | 117 | 0 |
| K232559 | C&B NFH Hybrid | Arum Dentistry Co., Ltd. | 2024-09-11 | 385 | 0 |
| K240603 | Ti-Base & Master Fix | Arum Dentistry Co., Ltd. | 2024-06-05 | 93 | 0 |
| K234112 | Customized Abutment | Arum Dentistry Co., Ltd. | 2024-05-09 | 134 | 0 |
| K240091 | NB Mini Implant System | Arum Dentistry Co., Ltd. | 2024-04-26 | 105 | 0 |
| K232560 | Angled Abutment | Arum Dentistry Co., Ltd. | 2023-12-19 | 118 | 0 |
| K230725 | NB Implant System | Arum Dentistry Co., Ltd. | 2023-07-01 | 107 | 0 |
| K223634 | Customized Abutment | Arum Dentistry Co., Ltd. | 2023-04-28 | 144 | 0 |
| K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | Arum Dentistry Co., Ltd. | 2023-02-27 | 129 | 0 |
| K222131 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022-09-19 | 63 | 0 |
| K213506 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022-04-06 | 156 | 0 |
| K210817 | C&B 5.0 Hybrid | Arum Dentistry Co., Ltd. | 2021-12-08 | 265 | 0 |
| K193425 | Pre-Milled Blank | Arum Dentistry Co., Ltd. | 2020-03-09 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda