Usbiomaterials Corp.: FDA clearances and approvals
Usbiomaterials Corp. has 5 FDA 510(k) clearances (first 1993, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time: 87 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | 4 | 4 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 | 1 |
Review panels
- Dental (5)
Most recent Usbiomaterials Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024343 | BUTLER GUM PROPHY PASTE WITH NOVAMIN | EJR | 2003-07-11 | 196 |
| K000149 | NOVABONE-BIOGLASS BONE GRAFT PARTICULATE | LYC | 2000-02-07 | 19 |
| K992416 | PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE | LYC | 1999-10-15 | 87 |
| K962494 | PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE | LYC | 1996-09-20 | 86 |
| K930115 | PERIOGLASS | LYC | 1993-11-04 | 297 |
Recalls
openFDA lists no recalls under a recalling firm named Usbiomaterials Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Usbiomaterials Corp. have?
Usbiomaterials Corp. has 5 FDA 510(k) clearances (first 1993, latest 2003), across 2 product codes in 1 review panel.
How long does FDA take to clear Usbiomaterials Corp.'s 510(k)s?
The median time from FDA receipt to decision across Usbiomaterials Corp.'s cleared 510(k)s is 87 days.
What devices does Usbiomaterials Corp. make?
Its most frequent FDA product codes are LYC (Bone Grafting Material, Synthetic, 4); EJR (Agent, Polishing, Abrasive, Oral Cavity, 1).
Has Usbiomaterials Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Usbiomaterials Corp. Related entities may recall under other names.
Next steps
- See all 5 Usbiomaterials Corp. clearances with predicates and recalls
- Run predicate analysis for product code LYC, Usbiomaterials Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.