K943370 is an FDA 510(k) clearance for the IMPULSE SEALER PRODUCT LINE. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 21, 1994, 100 days after receiving the submission on July 13, 1994.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K943370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 1994 |
| Decision Date | October 21, 1994 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJI — Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |