Austenal, Inc.: FDA clearances and approvals
Austenal, Inc. has 10 FDA 510(k) clearances (first 1992, latest 2001), across 6 product codes in 1 review panel. Median 510(k) review time: 57 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 3 | 3 |
| EIH | Powder, Porcelain | 2 | 2 |
| EJH | Alloy, Metal, Base | 2 | 2 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EJT | Alloy, Gold-Based Noble Metal | 1 | 1 |
| ELM | Denture, Plastic, Teeth | 1 | 1 |
Review panels
- Dental (10)
Most recent Austenal, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011674 | DC - CRISTAL | EIH | 2001-09-04 | 97 |
| K001815 | DC ZIRKON | EIH | 2000-08-10 | 56 |
| K001799 | DC-TELL | EBF | 2000-08-10 | 57 |
| K001798 | DC TITAN | EJH | 2000-07-31 | 47 |
| K970522 | MYERSON'S ECONOMY DENTURE BASE MATERIAL | EBI | 1997-05-14 | 92 |
| K970205 | VITALLIUM 2000 ALLOY; VITALLIUM 2000 PLUS ALLOY; COBALT CHROME CASTING ALLOY | EJH | 1997-04-21 | 90 |
| K955509 | MIDAS GOLD ELECTROFORMING SYSTEM | EJT | 1995-12-28 | 24 |
| K954810 | MYERSON IR DENTURE BASE | EBI | 1995-11-29 | 41 |
| K933468 | MYERSON'S PERMASOFT SOFT RELINE MATERIAL | EBI | 1994-01-05 | 173 |
| K924526 | DENTURE PLASTIC TEETH | ELM | 1992-11-04 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Austenal, Inc..
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 Austenal, Inc. have?
Austenal, Inc. has 10 FDA 510(k) clearances (first 1992, latest 2001), across 6 product codes in 1 review panel.
How long does FDA take to clear Austenal, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Austenal, Inc.'s cleared 510(k)s is 57 days.
What devices does Austenal, Inc. make?
Its most frequent FDA product codes are EBI (Resin, Denture, Relining, Repairing, Rebasing, 3); EIH (Powder, Porcelain, 2); EJH (Alloy, Metal, Base, 2).
Has Austenal, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Austenal, Inc. Related entities may recall under other names.
Next steps
- See all 10 Austenal, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Austenal, Inc.'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.