Dentis Co., Ltd.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Dentis Co., Ltd.” (first 2008, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 144 days. Since 2017 the median was 130 days, against 186 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 |
|---|---|---|
| 2012 | 1 | 261 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 2 | 320 |
| 2016 | 3 | 144 |
| 2017 | 3 | 154 |
| 2018 | 1 | 269 |
| 2019 | 0 | — |
| 2020 | 2 | 110 |
| 2021 | 6 | 160 |
| 2022 | 1 | 120 |
| 2023 | 9 | 115 |
| 2024 | 4 | 104 |
| 2025 | 1 | 337 |
| 2026 | 1 | 128 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dentis Co., Ltd. took a median 130 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 186 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 19 | 19 |
| NHA | Abutment, Implant, Dental, Endosseous | 13 | 13 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| KLC | Chair, Dental, With Operative Unit | 1 | 1 |
| NXC | Aligner, Sequential | 1 | 1 |
Review panels
- Dental (37)
Most recent Dentis Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253493 | Dentis SQ-SL AXEL Fixture | DZE | 2026-03-04 | 128 |
| K241065 | ChecQ (AC100) | EKX | 2025-03-21 | 337 |
| K233921 | Luvis Chair (LC700C) | KLC | 2024-09-06 | 268 |
| K241063 | s-Clean ScanHealing Abutment | NHA | 2024-07-25 | 98 |
| K240511 | Dentis s-Clean SQ-SL Fixture | DZE | 2024-05-20 | 88 |
| K233544 | MESHEET | NXC | 2024-02-22 | 111 |
| K230126 | Dentis s-Clean Regular Abutment | NHA | 2023-08-04 | 199 |
| K230307 | Dentis i-Clean System | NHA | 2023-07-11 | 158 |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant System | NHA | 2023-05-25 | 115 |
| K230523 | s-Clean Link Abutment Narrow | NHA | 2023-05-24 | 86 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dentis 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 Dentis Co., Ltd.?
FDA lists 37 510(k) clearances under the applicant name “Dentis Co., Ltd.” (first 2008, latest 2026), across 7 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 Dentis Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dentis Co., Ltd. is 144 days. Since 2017: 130 days, versus 186 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dentis Co., Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 19); NHA (Abutment, Implant, Dental, Endosseous, 13); DZL (Screw, Fixation, Intraosseous, 1).
Next steps
- See all 37 Dentis Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Dentis 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.