Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bosworth Co. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991687 | MODIFICATION TO LINER II: SOFT RELINE LIQUID | Bosworth Co. | 1999-10-07 | 143 | 0 |
| K991902 | LC PIT & FISSURE SEALANT | Bosworth Co. | 1999-07-26 | 52 | 0 |
| K953119 | BOSWORTH RESIN II | Bosworth Co. | 1995-08-28 | 56 | 0 |
| K810094 | DENTURE RUBBER BASE MATERIAL | Bosworth Co. | 1981-02-02 | 19 | 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