Den-Tal-Ez Mfg Co., Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Den-Tal-Ez Mfg Co., Inc.” (first 1978, latest 1993), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 70 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | 2 | 2 |
| KLC | Chair, Dental, With Operative Unit | 2 | 2 |
| EAZ | Light, Operating, Dental | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
Review panels
Most recent Den-Tal-Ez Mfg Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K925629 | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | EAZ | 1993-11-23 | 382 |
| K932824 | EVACUATOR, ORAL CAVITY | EIA | 1993-09-28 | 111 |
| K931204 | AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) | EIA | 1993-07-08 | 121 |
| K920017 | IMPROVED DENTAL OPERATING LIGHT | KLC | 1992-03-02 | 60 |
| K920016 | IMPROVED DENTAL CHAIR | KLC | 1992-03-02 | 60 |
| K874294 | AUTOCHUCK ATTACHMENT | EFB | 1987-12-29 | 70 |
| K780469 | PANORAMIC X-RAY, DENTAL | EHD | 1978-04-10 | 19 |
Recalls
openFDA lists no recalls under a recalling firm named Den-Tal-Ez Mfg Co., Inc..
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 Den-Tal-Ez Mfg Co., Inc.?
FDA lists 7 510(k) clearances under the applicant name “Den-Tal-Ez Mfg Co., Inc.” (first 1978, latest 1993), across 5 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 Den-Tal-Ez Mfg Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Den-Tal-Ez Mfg Co., Inc. is 70 days.
Which FDA product codes appear under Den-Tal-Ez Mfg Co., Inc.?
The most frequent FDA product codes under this applicant name are EIA (Unit, Operative Dental, 2); KLC (Chair, Dental, With Operative Unit, 2); EAZ (Light, Operating, Dental, 1).
Next steps
- See all 7 Den-Tal-Ez Mfg Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EIA, Den-Tal-Ez Mfg Co., Inc.'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.