K913974 is an FDA 510(k) clearance for the ACCESS IMPRESSION BARREL. This device is classified as a Syringe, Restorative And Impression Material (Class I - General Controls, product code EID).
Submitted by Centrix, Inc. (Milford, US). The FDA issued a Cleared decision on February 25, 1992, 172 days after receiving the submission on September 6, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.
| 510(k) Number | K913974 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1991 |
| Decision Date | February 25, 1992 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EID — Syringe, Restorative And Impression Material |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4565 |