Astron Dental Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Astron Dental Corp.” (first 1983, latest 2011), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 | 4 |
| JER | Cleaner, Denture, Mechanical | 1 | 1 |
| MQC | Mouthguard, Prescription | 1 | 1 |
Review panels
- Dental (6)
Most recent Astron Dental Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111828 | CLEARSPLINT ES | MQC | 2011-10-26 | 120 |
| K874025 | 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN | EBI | 1987-12-23 | 82 |
| K864757 | MODIFIED VINYLAC PRESS PACK DENTURE RESIN | EBI | 1987-02-10 | 67 |
| K852906 | DURACLEAN DENTURE CLEANER | JER | 1985-07-31 | 22 |
| K833270 | ASTRON 77 INJECTION DENTURE RESIN | EBI | 1984-07-19 | 302 |
| K831269 | VINYLAC PRESS-PACK DENTURE RESIN | EBI | 1983-06-08 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Astron Dental Corp..
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.
- Astron Clinica Limited (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Astron Dental Corp.?
FDA lists 6 510(k) clearances under the applicant name “Astron Dental Corp.” (first 1983, latest 2011), across 3 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 Astron Dental Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Astron Dental Corp. is 74 days.
Which FDA product codes appear under Astron Dental Corp.?
The most frequent FDA product codes under this applicant name are EBI (Resin, Denture, Relining, Repairing, Rebasing, 4); JER (Cleaner, Denture, Mechanical, 1); MQC (Mouthguard, Prescription, 1).
Next steps
- See all 6 Astron Dental Corp. clearances with predicates and recalls
- Run predicate analysis for product code EBI, Astron Dental Corp.'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.