DiaDent Group International: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “DiaDent Group International” (first 2013, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 178 days. Since 2017 the median was 169 days, against 117 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 |
|---|---|---|
| 2013 | 1 | 205 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 339 |
| 2020 | 10 | 194 |
| 2021 | 2 | 92 |
| 2022 | 2 | 97 |
| 2023 | 1 | 59 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 6 | 90 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name DiaDent Group International took a median 169 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 117 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KIF | Resin, Root Canal Filling | 6 | 6 |
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 4 | 4 |
| ELW | Material, Impression | 3 | 3 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 2 | 2 |
| EMA | Cement, Dental | 2 | 2 |
Review panels
- Dental (24)
Most recent DiaDent Group International 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254152 | Dia-X Sil Light Body | ELW | 2026-09-16 | 268 |
| K254142 | Dia-X Sil Heavy Body | ELW | 2026-09-16 | 268 |
| K261166 | DIA-CEM | EMA | 2026-07-09 | 91 |
| K261093 | DIAFIL | EBF | 2026-06-02 | 61 |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | EBF | 2026-05-19 | 48 |
| K254112 | Dia-X Sil Bite | ELW | 2026-03-19 | 90 |
| K231552 | Dia-Cem | EMA | 2023-07-28 | 59 |
| K220804 | Dia-X Bond Universal | KLE | 2022-06-15 | 89 |
| K213401 | DIAPLUS Universal | KLE | 2022-01-31 | 105 |
| K210421 | Diafil & Diafil Capsule | EBF | 2021-06-28 | 137 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named DiaDent Group International.
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 DiaDent Group International?
FDA lists 24 510(k) clearances under the applicant name “DiaDent Group International” (first 2013, 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 DiaDent Group International?
The median time from FDA receipt to decision across 510(k)s cleared under the name DiaDent Group International is 178 days. Since 2017: 169 days, versus 117 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under DiaDent Group International?
The most frequent FDA product codes under this applicant name are KIF (Resin, Root Canal Filling, 6); EBF (Material, Tooth Shade, Resin, 5); KLE (Agent, Tooth Bonding, Resin, 4).
Next steps
- See all 24 DiaDent Group International clearances with predicates and recalls
- Run predicate analysis for product code KIF, DiaDent Group International'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.