Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EMJ — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
47 daysmedian FDA review time
52 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K870589 | ELEVATOR, ROOT, SINGLE-ENDED | Military Engineering, Inc. | 1987-04-03 | 52 | 0 |
| K851717 | 880/1 TO 890/4 VARIOUS TYPES OF PERIOTEAL ELEVATOR | Artiberia | 1985-06-14 | 50 | 0 |
| K851713 | 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA | Artiberia | 1985-06-11 | 47 | 0 |
| K850906 | TACTILE PLUS DENTAL ELEVATORS | Ipco Corp. | 1985-04-12 | 38 | 0 |
| K821788 | BEACH DERIOSTEAL ELEVATOR, #2 STRAIGHT | Pacific Dental Corp. | 1982-07-06 | 19 | 0 |
| K771747 | PERIOSTEAL ELEVATOR | Depuy, Inc. | 1977-09-28 | 13 | 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