Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Espe Dental Products — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
42 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810950 | VISIO-SEAL | Espe Dental Products | 1981-04-29 | 22 | 0 |
| K802819 | KETAC-CEM IN REF. TO K802048 | Espe Dental Products | 1980-11-24 | 17 | 0 |
| K802049 | NIMETIC-DISPERS | Espe Dental Products | 1980-09-16 | 22 | 0 |
| K800031 | PERMADYNE POLYETHER RUBBER IMPRESSION | Espe Dental Products | 1980-02-05 | 29 | 0 |
| K771901 | CAPMIX | Espe Dental Products | 1977-10-20 | 13 | 0 |
| K771889 | UNIOLITE | Espe Dental Products | 1977-10-20 | 14 | 0 |
| K771120 | IMPREFLEX ALGINATE IMPRESSION MATERIAL | Espe Dental Products | 1977-08-03 | 42 | 0 |
| K771119 | PASTES, RESTORATIVE & TINTED, DEBTAL | Espe Dental Products | 1977-07-15 | 23 | 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