Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eurodent, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
197 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K894058 | ISODENT | Eurodent, Inc. | 1989-12-21 | 197 | 0 |
| K894061 | STUDIO UNO | Eurodent, Inc. | 1989-11-21 | 167 | 0 |
| K894060 | ESSE QUATTRO/ESSE UNO | Eurodent, Inc. | 1989-09-07 | 92 | 0 |
| K894059 | ISOLIGHT | Eurodent, Inc. | 1989-09-07 | 92 | 0 |
| K790078 | BAR & RIDER, SCREWS, TUBES | Eurodent, Inc. | 1979-02-27 | 48 | 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