Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NDP · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193405 | Simplant Digital Guide | Dentsply Sirona | 2020-09-02 | 268 | 0 |
| K190059 | CEREC Guides | Dentsply Sirona | 2019-09-27 | 259 | 0 |
| K170849 | SIMPLANT Guide | Dentsply Sirona | 2017-06-15 | 85 | 0 |
| K070290 | SPI VECTODRILL CERAMIC DRILLS | Thommen Medical AG | 2007-04-17 | 77 | 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