Cleared Special

K142414 - Miltex N-Tralig Intraligamentary Syringe

K142414 is the FDA 510(k) clearance for Miltex N-Tralig Intraligamentary Syringe by Integra LifeSciences Corporation. It is a Class 2 Dental device (product code EJI) cleared through the Special 510(k) pathway after a 63-day FDA review.

K142414 · Integra LifeSciences Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
63d
Days
Class 2
Risk

K142414 is an FDA 510(k) clearance for the Miltex N-Tralig Intraligamentary Syringe. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on October 30, 2014 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Integra LifeSciences Corporation devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJI Syringe, Cartridge

Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K142414.
COMFORT CONTROL SYRINGE SYSTEM
K002387 · Dentsply Intl. · Sep 2000
IMPULSE SEALER PRODUCT LINE
K943370 · Ultradent Products, Inc. · Oct 1994
CITOJECT CARTRIDGE SYRINGE
K842006 · Miles Laboratories, Inc. · Jul 1984
MULTI-PURPOSE DENTAL SYRINGE
K811831 · Centrix, Inc. · Sep 1981
MONOJECT PLASTIC DENTAL INJ. SYRINGE
K792541 · Sherwood Medical Co. · Feb 1980