Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
ELY · 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) |
|---|---|---|---|---|---|
| K093587 | DENTAL MERCURY | Dmg USA, Inc. | 2010-01-21 | 63 | 0 |
| K973548 | MERCURY DENTAL | Aleaciones Dentales Zeyco, S.A. DE C.V. | 1998-03-23 | 186 | 0 |
| K913814 | MODEL #05 ANEROID SPHYGMOMANOMETER KIT | National Health-Care Equipment, Inc. | 1992-01-16 | 143 | 0 |
| K902388 | DENTAL-QUECKSILBER (DENTAL MERCURY) | Degussa AG | 1990-06-28 | 29 | 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