Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S-Denti Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112508 | I-ROOT 100 | S-Denti Co., Ltd. | 2012-06-19 | 294 | 0 |
| K112153 | IROOT 100 MINI | S-Denti Co., Ltd. | 2012-04-26 | 294 | 0 |
| K100450 | I-ROOT | S-Denti Co., Ltd. | 2010-11-18 | 274 | 0 |
| K083901 | NAVI ROOT | S-Denti Co., Ltd. | 2009-04-15 | 107 | 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