Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentamerica — 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) |
|---|---|---|---|---|---|
| K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | Dentamerica | 2010-01-07 | 114 | 0 |
| K060640 | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM | Dentamerica | 2006-04-24 | 45 | 0 |
| K954820 | SCALEX 800 | Dentamerica | 1996-01-18 | 90 | 0 |
| K955759 | LITEX 680 | Dentamerica | 1996-01-02 | 15 | 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