Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EKH · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K823321 | DENTAL INSTRUMENTS - CARVER | Miltex, Inc. | 1982-11-24 | 16 | 0 |
| K821785 | BEACH AMALGAM CARVER | Pacific Dental Corp. | 1982-07-06 | 19 | 0 |
| K780528 | PREMIER CARVERS, STYLE #21C & 21D | Premier Dental Products Co. | 1978-04-19 | 16 | 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