Dentium Co., Ltd.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Dentium Co., Ltd.” (first 2004, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 174 days. Since 2017 the median was 191 days, against 193 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 | 2 | 228 |
| 2013 | 0 | — |
| 2014 | 1 | 163 |
| 2015 | 0 | — |
| 2016 | 4 | 176 |
| 2017 | 3 | 191 |
| 2018 | 2 | 239 |
| 2019 | 1 | 138 |
| 2020 | 2 | 208 |
| 2021 | 0 | — |
| 2022 | 1 | 100 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dentium Co., Ltd. took a median 191 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 193 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 13 | 13 |
| DZE | Implant, Endosseous, Root-Form | 9 | 9 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 1 |
Review panels
- Dental (23)
Most recent Dentium Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213599 | SuperLine | DZE | 2022-02-23 | 100 |
| K193341 | iCTmotor (WL-1) | EBW | 2020-09-04 | 276 |
| K192436 | Healing Abutments and Cover Screws | NHA | 2020-01-23 | 139 |
| K191634 | Scan Abutments and Comfort Caps | NHA | 2019-11-04 | 138 |
| K172640 | Dentium Implantium & SuperLine Prosthetics | NHA | 2018-05-14 | 255 |
| K171622 | Dentium Ti-Base | NHA | 2018-01-11 | 223 |
| K171126 | Implantium II | DZE | 2017-09-07 | 143 |
| K170384 | Dentium NR Line CAD/CAM Abutments | NHA | 2017-08-17 | 191 |
| K160965 | SuperLine | DZE | 2017-01-13 | 282 |
| K161713 | Dentium CAD/CAM Abutments | NHA | 2016-12-16 | 178 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dentium 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Dentium Co., Ltd (Ict Branch) (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dentium Co., Ltd.?
FDA lists 23 510(k) clearances under the applicant name “Dentium Co., Ltd.” (first 2004, latest 2022), across 3 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 Dentium Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dentium Co., Ltd. is 174 days. Since 2017: 191 days, versus 193 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Dentium Co., Ltd.?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 13); DZE (Implant, Endosseous, Root-Form, 9); EBW (Controller, Foot, Handpiece And Cord, 1).
Next steps
- See all 23 Dentium Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Dentium 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.