Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EHL — 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) |
|---|---|---|---|---|---|
| K792250 | CUTTER POINTS | Cutter Laboratories, Inc. | 1980-01-23 | 76 | 0 |
| K780811 | DENTAL ABRASIVE DEVICE | Cavitron Corp. | 1978-06-22 | 35 | 0 |
| K780376 | MINIDENTOFLEX NEW POLISHING SYSTEM | Cavitron Corp. | 1978-03-14 | 6 | 0 |
| K780377 | PINIDENTOFLEX DENTAL POLISHER | Cavitron Corp. | 1978-03-14 | 6 | 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