Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
EEF · 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) |
|---|---|---|---|---|---|
| K071615 | FIXAFLOSS | Sybron Dental Specialties, Inc. | 2007-09-21 | 100 | 0 |
| K915207 | DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP | Bay Technical Products, Inc. | 1992-02-14 | 88 | 0 |
| K780744 | BRINKER TISSUE RETRACTORS | Hygienic Dental Mfg., Co., The | 1978-05-12 | 29 | 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