Cleared Special

Miltex N-Tralig Intraligamentary Syringe

K142414 · Integra LifeSciences Corporation · Dental
Oct 2014
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K142414 is an FDA 510(k) clearance for the Miltex N-Tralig Intraligamentary Syringe, 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 review panel. Regulated under 21 CFR 872.6770.

Submission Details

510(k) Number K142414 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EJI — Syringe, Cartridge
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.6770

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