Bio-Interfaces, Inc.
San Diego, CA, US
Bio-Interfaces, Inc. appears in FDA device records in San Diego, CA. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Bio-Interfaces, Inc. between 1989 and 1996. The busiest year on record is 1994, with 5. The most recent is 1996, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1992 | 1 |
| 1993 | 4 |
| 1994 | 5 |
| 1995 | 3 |
| 1996 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K960164 | BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140 | LYC | Substantially Equivalent | |
| K954763 | BIO-INTERFACES, INC,. BII-PLAST | LYC | Substantially Equivalent | |
| K950598 | BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT | LYC | Substantially Equivalent | |
| K950567 | BIO-APATITE 6140 HA PARTICLES | LYC | Substantially Equivalent | |
| K950511 | BLL-FIL 6140 PARTICLES | LYC | Substantially Equivalent | |
| K934049 | BII-PORE(TM) CANAL WALL PROSTHESIS | LYC | Substantially Equivalent | |
| K933688 | BII-PORE | LYC | Substantially Equivalent | |
| K941431 | BONE GRAFT DELIVERY SYRINGES | EID | Substantially Equivalent | |
| K934430 | BON APATITE HA PARTICLES | LYC | Substantially Equivalent | |
| K934947 | BII-PLAST | LYC | Substantially Equivalent | |
| K924287 | 710 POROUS HA PARTICLES-BII-PORE | LYC | Substantially Equivalent | |
| K924288 | B1018 POROUS HA BII-PORE | LYC | Substantially Equivalent | |
| K924286 | 4060 POROUS HA PARTICULES BII PORE | LYC | Substantially Equivalent | |
| K922487 | BIO-INTERFACES 1840 POROUS HA PARTICLES-BII-PORE | LYC | Substantially Equivalent | |
| K921776 | 1840 HA PARTICLES | LYC | Substantially Equivalent | |
| K884732 | SUPERIOR ENDOSSEOUS DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | |
| K885067 | 4060 HA PARTICLES | LYC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain