Itena Clinical: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Itena Clinical” (first 2013, latest 2017), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 256 days. 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 | 6 | 279 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 164 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Itena Clinical took a median 164 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 |
|---|---|---|---|
| EMA | Cement, Dental | 4 | 4 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| KIF | Resin, Root Canal Filling | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (8)
Most recent Itena Clinical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170207 | Obturys | KIF | 2017-07-31 | 188 |
| K162960 | TotalC-Ram | EMA | 2017-03-14 | 141 |
| K122551 | PROVITEMP | EMA | 2013-06-14 | 297 |
| K122521 | PREVENT SEAL | EBC | 2013-06-11 | 295 |
| K122549 | DENTO TEMP | EMA | 2013-04-26 | 248 |
| K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | EMA | 2013-04-19 | 304 |
| K122522 | DENTOETCH QUICKBOND BOND ACTIVATOR | KLE | 2013-03-19 | 211 |
| K121769 | DENTOCORE / DENTOCORE BODY | EBF | 2013-03-05 | 263 |
Recalls
openFDA lists no recalls under a recalling firm named Itena Clinical.
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 Itena Clinical?
FDA lists 8 510(k) clearances under the applicant name “Itena Clinical” (first 2013, latest 2017), 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 Itena Clinical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Itena Clinical is 256 days.
Which FDA product codes appear under Itena Clinical?
The most frequent FDA product codes under this applicant name are EMA (Cement, Dental, 4); EBC (Sealant, Pit And Fissure, And Conditioner, 1); EBF (Material, Tooth Shade, Resin, 1).
Next steps
- See all 8 Itena Clinical clearances with predicates and recalls
- Run predicate analysis for product code EMA, Itena Clinical'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.