Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Septodont, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
12 daysmedian FDA review time
65 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K780003 | ENDOSOLV E | Septodont, Inc. | 1978-01-20 | 22 | 0 |
| K771114 | NEUTROCIM | Septodont, Inc. | 1978-01-04 | 197 | 0 |
| K761355 | SELFAST | Septodont, Inc. | 1977-01-03 | 5 | 0 |
| K761354 | CIMPAT (PINK AND WHITE) | Septodont, Inc. | 1977-01-03 | 5 | 0 |
| K760798 | FLUOCAL GEL MINT | Septodont, Inc. | 1976-11-24 | 47 | 0 |
| K760799 | FLUOCAL GEL ORANGE | Septodont, Inc. | 1976-11-24 | 47 | 0 |
| K761024 | RACESTYPTINE RINGS | Septodont, Inc. | 1976-11-19 | 65 | 0 |
| K760658 | DETARTRINE P | Septodont, Inc. | 1976-09-27 | 12 | 0 |
| K760660 | HYDROL | Septodont, Inc. | 1976-09-27 | 12 | 0 |
| K760657 | RACESTYPTINE CORD | Septodont, Inc. | 1976-09-27 | 12 | 0 |
| K760659 | CALCIPULPE | Septodont, Inc. | 1976-09-27 | 12 | 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