Hygienic Dental Mfg., Co., The: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Hygienic Dental Mfg., Co., The” (first 1977, latest 1978), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 29 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 |
|---|---|---|---|
| EJE | Frame, Rubber Dam | 2 | 2 |
| ECI | Band, Elastic, Orthodontic | 1 | 1 |
| EEF | Clamp, Rubber Dam | 1 | 1 |
| EIE | Dam, Rubber | 1 | 1 |
| EJG | Forceps, Rubber Dam Clamp | 1 | 1 |
Review panels
- Dental (6)
Most recent Hygienic Dental Mfg., Co., The 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K780804 | HYGIENIC ANCHORINGS | ECI | 1978-06-14 | 34 |
| K780746 | HYGIENIC RUBBER DAM FRAME | EJE | 1978-05-12 | 29 |
| K780745 | RUBBER DAM | EIE | 1978-05-12 | 29 |
| K780744 | BRINKER TISSUE RETRACTORS | EEF | 1978-05-12 | 29 |
| K780743 | CLAMP FORCEPS | EJG | 1978-05-12 | 29 |
| K770117 | HYGIENIC 5 & 6 RUBBER DAM FRAME | EJE | 1977-01-28 | 7 |
Recalls
openFDA lists no recalls under a recalling firm named Hygienic Dental Mfg., Co., The.
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 Hygienic Dental Mfg., Co., The?
FDA lists 6 510(k) clearances under the applicant name “Hygienic Dental Mfg., Co., The” (first 1977, latest 1978), 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 Hygienic Dental Mfg., Co., The?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hygienic Dental Mfg., Co., The is 29 days.
Which FDA product codes appear under Hygienic Dental Mfg., Co., The?
The most frequent FDA product codes under this applicant name are EJE (Frame, Rubber Dam, 2); ECI (Band, Elastic, Orthodontic, 1); EEF (Clamp, Rubber Dam, 1).
Next steps
- See all 6 Hygienic Dental Mfg., Co., The clearances with predicates and recalls
- Run predicate analysis for product code EJE, Hygienic Dental Mfg., Co., The'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.