K941431 is an FDA 510(k) clearance for the BONE GRAFT DELIVERY SYRINGES. This device is classified as a Syringe, Restorative And Impression Material (Class I - General Controls, product code EID).
Submitted by Bio-Interfaces, Inc. (San Diego, US). The FDA issued a Cleared decision on July 12, 1994, 110 days after receiving the submission on March 24, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K941431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 1994 |
| Decision Date | July 12, 1994 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EID — Syringe, Restorative And Impression Material |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |