510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081694Substantially Equivalent

Denjector

Dxm Co., Ltd., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081694 is the FDA 510(k) clearance record for DENJECTOR, a class II device, cleared for Dxm Co., Ltd. on under FDA product code EJI (Syringe, Cartridge). FDA records list 4 510(k) clearances for Dxm Co., Ltd., from to . As of , FDA records show no recalls naming K081694.

Clearance record

Decision date
Received
(87 days to decision)
Product code
EJI Syringe, Cartridge
Regulation
21 CFR 872.6770
Device class
Class II
Review panel
Dental
Applicant
Dxm Co., Ltd. 55 Northern Blvd., Suite 200, Great Neck NY
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