K142414 is an FDA 510(k) clearance for the Miltex N-Tralig Intraligamentary Syringe. This device is classified as a Syringe, Cartridge (Class II - Special Controls, product code EJI).
Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on October 30, 2014, 63 days after receiving the submission on August 28, 2014.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6770.
| 510(k) Number | K142414 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2014 |
| Decision Date | October 30, 2014 |
| Days to Decision | 63 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EJI — Syringe, Cartridge |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6770 |