Austenal Dental, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Austenal Dental, Inc.” (first 1985, latest 1989), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | 6 | 6 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 5 | 5 |
| EJS | Alloy, Other Noble Metal | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
| EJW | Clasp, Wire | 1 | 1 |
| EKG | Condenser, Amalgam And Foil, Operative | 1 | 1 |
| ELM | Denture, Plastic, Teeth | 1 | 1 |
| ELW | Material, Impression | 1 | 1 |
Review panels
- Dental (19)
Most recent Austenal Dental, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K890713 | OVERDENTURE - STUD ATTACHMENT | DZE | 1989-07-14 | 151 |
| K883799 | BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN | EBI | 1988-10-20 | 43 |
| K880875 | VITALLIUM EQUIPOISE ALLOY | EJH | 1988-04-07 | 37 |
| K871849 | LIGHT CURE DENTURE GLAZE | EBI | 1987-08-10 | 90 |
| K872746 | VITALLIUM WIRE | EJW | 1987-07-21 | 8 |
| K863630 | AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL | EBI | 1987-03-11 | 175 |
| K865025 | AUSTENAL CONDENSING INSTRUMENT | EKG | 1987-02-19 | 58 |
| K862557 | AUSTENAL ACUSOFT SOFT LINER | EBI | 1987-02-19 | 231 |
| K864826 | A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) | EJH | 1987-02-10 | 63 |
| K862856 | PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR | EJS | 1986-08-26 | 28 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Austenal Dental, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Austenal, Inc. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Austenal Dental, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Austenal Dental, Inc.” (first 1985, latest 1989), across 9 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 Austenal Dental, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Austenal Dental, Inc. is 50 days.
Which FDA product codes appear under Austenal Dental, Inc.?
The most frequent FDA product codes under this applicant name are EJH (Alloy, Metal, Base, 6); EBI (Resin, Denture, Relining, Repairing, Rebasing, 5); EJS (Alloy, Other Noble Metal, 2).
Next steps
- See all 19 Austenal Dental, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJH, Austenal Dental, 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.