Cleared Traditional

K171254 - LeEject 2 Dental Syringe and Needle System

K171254 is an FDA 510(k) clearance for LeEject 2 Dental Syringe and Needle System, manufactured by Advanced Technology and Capital, Inc.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K171254 · Advanced Technology and Capital, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
202d
Days
Class 2
Risk

K171254 is an FDA 510(k) clearance for the LeEject 2 Dental Syringe and Needle System. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Advanced Technology and Capital, Inc. (Englewood Cliffs, US). The FDA issued a Cleared decision on November 16, 2017 after a review of 202 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K171254

510(k) Number K171254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2017
Decision Date November 16, 2017
Days to Decision 202 days
Submission Type Traditional
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
74d slower than avg
Panel avg: 128d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJI Device Classification - Class 2, Special Controls

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 Consultant

Smith Associates
E.J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EJI Syringe, Cartridge

All 36
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K171254.
Miltex N-Tralig Intraligamentary Syringe
K142414 · Integra LifeSciences Corporation · Oct 2014
HU-FRIEDY DENTAL CARTRIDGE SYRINGE
K120659 · Hu-Friedy Mfg. Co., LLC · Nov 2012
ANESTHESIA INJECTION TOOL SET
K113247 · Ki Works Co., Ltd. · Mar 2012
MORPHEUS
K082249 · Meibach Tech Ltda · Dec 2009
ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
K092943 · Arnold Tuber Industries · Dec 2009
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
K083796 · Miltex, Inc. · Mar 2009
K171254 · LeEject 2 Dental Syringe and Needle System
Download PDF FDA Summary Advanced Technology a…