Mediclus Co., Ltd.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Mediclus Co., Ltd.” (first 2023, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 115 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 |
|---|---|---|
| 2023 | 1 | 90 |
| 2024 | 2 | 170 |
| 2025 | 6 | 92 |
| 2026 | 7 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mediclus Co., Ltd. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| KIF | Resin, Root Canal Filling | 4 | 4 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
| EJK | Liner, Cavity, Calcium Hydroxide | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| MVL | Cord, Retraction | 1 | 1 |
Review panels
- Dental (16)
Most recent Mediclus Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262074 | Any-Zircos | EIH | 2026-08-21 | 60 |
| K254201 | Any-Cem | EMA | 2026-08-13 | 227 |
| K261728 | One-Fil LC | EJK | 2026-07-21 | 56 |
| K260485 | Any-Etch | KLE | 2026-05-14 | 90 |
| K260819 | Any-Com Seal | EBC | 2026-05-01 | 49 |
| K253797 | One-Stop | MVL | 2026-02-27 | 91 |
| K253167 | Any-Paste | KIF | 2026-01-12 | 108 |
| K252465 | Any-Core | EBF | 2025-12-05 | 121 |
| K251884 | One-Fil Putty Injectable | KIF | 2025-08-22 | 63 |
| K251283 | Once-Fil Flow | EBF | 2025-06-06 | 42 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mediclus 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 Mediclus Co., Ltd.?
FDA lists 16 510(k) clearances under the applicant name “Mediclus Co., Ltd.” (first 2023, latest 2026), across 8 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 Mediclus Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mediclus Co., Ltd. is 90 days. Since 2017: 90 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Mediclus Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 5); KIF (Resin, Root Canal Filling, 4); KLE (Agent, Tooth Bonding, Resin, 2).
Next steps
- See all 16 Mediclus Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Mediclus 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.