Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EKP — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
21 daysmedian FDA review time
62 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823686 | REAMER TYPE K ENDODONTIC | United Dental Mfg., Inc. | 1982-12-28 | 21 | 0 |
| K822620 | ROOT CANAL REAMERS, TYPE K | Union Broach, Div. Moyco Industries, Inc. | 1982-09-28 | 29 | 0 |
| K800291 | ENDEX REAMERS PULP CANAL, ENDODONTIC | Ipco Corp. | 1980-02-19 | 8 | 0 |
| K770331 | DIALYSIS, JET SYSTEM | Janneck Ent. of Texas | 1977-04-20 | 62 | 0 |
| K770598 | ENDODONTIC INSTRUMENTS, R&R CUTWELL | Ransom and Randolph | 1977-04-05 | 7 | 0 |
| K770367 | ROOT CANAL FILES & REAMERS | Cemco Tool Co., Inc. | 1977-03-01 | 7 | 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