Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dent Corp. Research & Development — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K063659 | EASY CURING PEN-STYLE LED CURING LIGHT | Dent Corp. Research & Development | 2007-04-30 | 143 | 0 |
| K020206 | INTRAORAL CAMERA ME-15 | Dent Corp. Research & Development | 2002-04-11 | 79 | 0 |
| K992233 | APEX LOCATOR BINGO-1020 | Dent Corp. Research & Development | 1999-11-30 | 158 | 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