K811831 is an FDA 510(k) clearance for the MULTI-PURPOSE DENTAL SYRINGE. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Centrix, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981, 71 days after receiving the submission on June 29, 1981.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K811831 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1981 |
| Decision Date | September 08, 1981 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EJI — Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |