Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EIK · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
195 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013993 | NEOCALEX | Stephen M Koral, Dmd | 2002-02-22 | 80 | 0 |
| K972642 | PERIO CONTROL II | Estrad B.V. | 1998-01-26 | 195 | 0 |
| K902653 | PDS-2000 | Intl. Equipment and Supply Corp. | 1990-09-13 | 90 | 0 |
| K860817 | ROOT CANAL ORGANIZER | Pacific Union Dental, Inc. | 1986-03-17 | 13 | 0 |
| K851727 | 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA | Artiberia | 1985-07-02 | 68 | 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