Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Usbiomaterials Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
297 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K024343 | BUTLER GUM PROPHY PASTE WITH NOVAMIN | Usbiomaterials Corp. | 2003-07-11 | 196 | 0 |
| K000149 | NOVABONE-BIOGLASS BONE GRAFT PARTICULATE | Usbiomaterials Corp. | 2000-02-07 | 19 | 0 |
| K992416 | PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE | Usbiomaterials Corp. | 1999-10-15 | 87 | 0 |
| K962494 | PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE | Usbiomaterials Corp. | 1996-09-20 | 86 | 0 |
| K930115 | PERIOGLASS | Usbiomaterials Corp. | 1993-11-04 | 297 | 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