Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Astron Dental Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
302 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874025 | 2ND MODIFIED VINYLAC PRESS PACK DENTURE RESIN | Astron Dental Corp. | 1987-12-23 | 82 | 0 |
| K864757 | MODIFIED VINYLAC PRESS PACK DENTURE RESIN | Astron Dental Corp. | 1987-02-10 | 67 | 0 |
| K852906 | DURACLEAN DENTURE CLEANER | Astron Dental Corp. | 1985-07-31 | 22 | 0 |
| K833270 | ASTRON 77 INJECTION DENTURE RESIN | Astron Dental Corp. | 1984-07-19 | 302 | 0 |
| K831269 | VINYLAC PRESS-PACK DENTURE RESIN | Astron Dental Corp. | 1983-06-08 | 51 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda