Denar Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Denar Corp.” (first 1985, latest 1992), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 81 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 3 | 3 |
| IWY | Holder, Head, Radiographic | 1 | 1 |
| IZT | Cone, Radiographic | 1 | 1 |
Review panels
Most recent Denar Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925705 | ACCURAD-200 SYSTEM & ACCURAD-300 PLUS SYSTEM | IWY | 1992-12-28 | 46 |
| K924759 | COLLIMATOR LIGHT SOURCE | IZT | 1992-12-09 | 77 |
| K884845 | STERI-OSS | DZE | 1989-02-10 | 81 |
| K883373 | STERI-OSS HYDROXYAPATITE-COATED DENTAL IMPLANT | DZE | 1989-01-13 | 157 |
| K852802 | DENAR DENTAL IMPLANT | DZE | 1985-09-23 | 82 |
Recalls
openFDA lists no recalls under a recalling firm named Denar Corp..
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 Denar Corp.?
FDA lists 5 510(k) clearances under the applicant name “Denar Corp.” (first 1985, latest 1992), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Denar Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Denar Corp. is 81 days.
Which FDA product codes appear under Denar Corp.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 3); IWY (Holder, Head, Radiographic, 1); IZT (Cone, Radiographic, 1).
Next steps
- See all 5 Denar Corp. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Denar Corp.'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.