K081694 is an FDA 510(k) clearance for the DENJECTOR. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Dxm Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 12, 2008, 87 days after receiving the submission on June 17, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K081694 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2008 |
| Decision Date | September 12, 2008 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJI - Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |