510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K171254Substantially Equivalent

LeEject 2 Dental Syringe and Needle System

Advanced Technology and Capital, Inc., Englewood Cliffs NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K171254 is the FDA 510(k) clearance record for LeEject 2 Dental Syringe and Needle System, a class II device, cleared for Advanced Technology and Capital, Inc. on under FDA product code EJI (Syringe, Cartridge). FDA records list one 510(k) clearance for Advanced Technology and Capital, Inc. As of , FDA records show no recalls naming K171254.

Clearance record

Decision date
Received
(202 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Advanced Technology and Capital, Inc. 5 Sylvan Ave., Englewood Cliffs NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EJI

Trailing 12 months

FDA records hold no clearances under product code EJI in the trailing twelve months.

FDA records show no clearances under product code EJI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EJI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260