Cleared Traditional

LeEject 2 Dental Syringe and Needle System

K171254 · Advanced Technology and Capital, Inc. · Dental

Nov 2017

Decision

202d

Days

Class 2

Risk

About This 510(k) Submission

K171254 is an FDA 510(k) clearance for the LeEject 2 Dental Syringe and Needle System, a Syringe, Cartridge (Class II — Special Controls, product code EJI), submitted by Advanced Technology and Capital, Inc. (Englewood Cliffs, US). The FDA issued a Cleared decision on November 16, 2017, 202 days after receiving the submission on April 28, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.6770.

Submission Details

510(k) Number	K171254 FDA.gov
FDA Decision	Cleared 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