Arum Dentistry Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Arum Dentistry Co., Ltd.” (first 2020, latest 2025), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 129 days. Since 2017 the median was 129 days, against 163 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 1 | 90 |
| 2021 | 1 | 265 |
| 2022 | 2 | 110 |
| 2023 | 4 | 124 |
| 2024 | 5 | 117 |
| 2025 | 4 | 177 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Arum Dentistry Co., Ltd. took a median 129 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 163 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 7 | 7 |
| NHA | Abutment, Implant, Dental, Endosseous | 6 | 6 |
| EIH | Powder, Porcelain | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
Review panels
- Dental (17)
Most recent Arum Dentistry Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250280 | SD TL Implant System | DZE | 2025-07-23 | 173 |
| K250063 | ARENA Star, Galaxy Star | EIH | 2025-07-10 | 181 |
| K241703 | SD Implant System | DZE | 2025-02-24 | 256 |
| K242753 | SD TL Implant System | DZE | 2025-01-06 | 116 |
| K242245 | Customized Abutment | NHA | 2024-11-25 | 117 |
| K232559 | C&B NFH Hybrid | EBF | 2024-09-11 | 385 |
| K240603 | Ti-Base & Master Fix | NHA | 2024-06-05 | 93 |
| K234112 | Customized Abutment | NHA | 2024-05-09 | 134 |
| K240091 | NB Mini Implant System | DZE | 2024-04-26 | 105 |
| K232560 | Angled Abutment | NHA | 2023-12-19 | 118 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Arum Dentistry Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Arum Dentistry Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Arum Dentistry Co., Ltd.” (first 2020, latest 2025), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Arum Dentistry Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Arum Dentistry Co., Ltd. is 129 days. Since 2017: 129 days, versus 163 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Arum Dentistry Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 7); NHA (Abutment, Implant, Dental, Endosseous, 6); EIH (Powder, Porcelain, 2).
Next steps
- See all 17 Arum Dentistry Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Arum Dentistry Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.