The Hygenic Corp.: FDA clearances and approvals
The Hygenic Corp. has 16 FDA 510(k) clearances (first 1979, latest 1996), across 11 product codes in 3 review panels. Median 510(k) review time: 108 days.
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 |
|---|---|---|---|
| EAT | Tester, Pulp | 3 | 3 |
| EGD | Wax, Dental, Intraoral | 3 | 3 |
| EIE | Dam, Rubber | 2 | 2 |
| DZA | Drill, Dental, Intraoral | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EKM | Gutta-Percha | 1 | 1 |
| EKS | File, Pulp Canal, Endodontic | 1 | 1 |
| KGS | Retention Device, Suture | 1 | 1 |
| KIF | Resin, Root Canal Filling | 1 | 1 |
| KMJ | Lubricant, Patient | 1 | 1 |
Plus 1 more product codes.
Review panels
- Dental (14)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent The Hygenic Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K954990 | DENTAL DAM | EIE | 1996-01-26 | 87 |
| K930764 | ENDO-ICE-PULP TESTER-THERMAL | EAT | 1993-05-27 | 104 |
| K905418 | GATES GLIDDEN DRILLS | DZA | 1991-07-25 | 233 |
| K911225 | TRAY DOUGH | KGS | 1991-04-17 | 27 |
| K905640 | SOLID CORE GUTTA PERCHA CARRIER | EKS | 1991-03-05 | 78 |
| K900301 | NOVUS BONDING AGENT | EBI | 1990-05-15 | 113 |
| K900844 | WEDJETS | EIE | 1990-04-16 | 53 |
| K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | KIF | 1990-01-10 | 216 |
| K881826 | ENDO-ICE | EAT | 1988-08-23 | 116 |
| K873644 | PULP PEN | EAT | 1987-10-27 | 48 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named The Hygenic Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does The Hygenic Corp. have?
The Hygenic Corp. has 16 FDA 510(k) clearances (first 1979, latest 1996), across 11 product codes in 3 review panels.
How long does FDA take to clear The Hygenic Corp.'s 510(k)s?
The median time from FDA receipt to decision across The Hygenic Corp.'s cleared 510(k)s is 108 days.
What devices does The Hygenic Corp. make?
Its most frequent FDA product codes are EAT (Tester, Pulp, 3); EGD (Wax, Dental, Intraoral, 3); EIE (Dam, Rubber, 2).
Has The Hygenic Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching The Hygenic Corp. Related entities may recall under other names.
Next steps
- See all 16 The Hygenic Corp. clearances with predicates and recalls
- Run predicate analysis for product code EAT, The Hygenic Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.