Cleared Traditional

K171254 - LeEject 2 Dental Syringe and Needle System (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171254 · Advanced Technology and Capital, Inc. · Dental device
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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.

View all Advanced Technology and Capital, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 127d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.