Bio-Interfaces, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Bio-Interfaces, Inc.” (first 1989, latest 1996), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 195 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 15 | 15 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| EID | Syringe, Restorative And Impression Material | 1 | 1 |
Review panels
- Dental (17)
Most recent Bio-Interfaces, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960164 | BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140 | LYC | 1996-04-10 | 85 |
| K954763 | BIO-INTERFACES, INC,. BII-PLAST | LYC | 1996-01-04 | 79 |
| K950598 | BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT | LYC | 1995-08-23 | 195 |
| K950567 | BIO-APATITE 6140 HA PARTICLES | LYC | 1995-05-09 | 90 |
| K950511 | BLL-FIL 6140 PARTICLES | LYC | 1995-04-27 | 80 |
| K934049 | BII-PORE(TM) CANAL WALL PROSTHESIS | LYC | 1994-07-19 | 334 |
| K933688 | BII-PORE | LYC | 1994-07-19 | 355 |
| K941431 | BONE GRAFT DELIVERY SYRINGES | EID | 1994-07-12 | 110 |
| K934430 | BON APATITE HA PARTICLES | LYC | 1994-05-18 | 247 |
| K934947 | BII-PLAST | LYC | 1994-01-26 | 100 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio-Interfaces, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio-Interfaces, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Bio-Interfaces, Inc.” (first 1989, latest 1996), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bio-Interfaces, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Interfaces, Inc. is 195 days.
Which FDA product codes appear under Bio-Interfaces, Inc.?
The most frequent FDA product codes under this applicant name are LYC (Bone Grafting Material, Synthetic, 15); DZE (Implant, Endosseous, Root-Form, 1); EID (Syringe, Restorative And Impression Material, 1).
Next steps
- See all 17 Bio-Interfaces, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYC, Bio-Interfaces, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.