Data / Medical devices / China / Denjoy Dental Co., Ltd

Denjoy Dental Co., Ltd: FDA-registered device maker in Changsha city Hunan, China, 1 510(k) clearance

Name: Denjoy Dental Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Denjoy Dental Co., Ltd is registered with the FDA (registration 3008590661) in Changsha city Hunan, China. It lists 17 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 13, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008590661
Address: F4, A4 Bld, Lugu Medical Device Park No. 229 Guyuan Road, Changsha city Hunan, China, 410205
Owner or operator: DENJOY DENTAL CO., LTD (10034843)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler
First device listed: February 16, 2011
Registered through: 2026
Brand names listed: Dental Suction Unit, ENDO HAND FILE, ENDO MOTOR,ENDO TREATMENT INSTRUMENT, LOW-VOLTAGE ELECTRIC MOTOR, Face Shield, HAND FILE, ROTARY FILE, INTRAORAL CAMERA, Integrated Endo System (Meet Endo-II), JAS Activator and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Accessory, Surgical Apparel	LYU	1	Manufacturer	accessdata.fda.gov
Camera, Cine, Endoscopic, With Audio	FTS	1	Manufacturer	accessdata.fda.gov
Dental Prophylaxis Kit	NYC	1	Manufacturer	accessdata.fda.gov
Endodontic Kit	NYD	2	Manufacturer	accessdata.fda.gov
File, Pulp Canal, Endodontic	EKS	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gutta-Percha	EKM	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Heat Source For Bleaching Teeth	EEG	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	KIJ	1	Manufacturer	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Manufacturer	accessdata.fda.gov
Locator, Root Apex	LQY	U	Manufacturer	accessdata.fda.gov
Microscope, Surgical, General & Plastic Surgery	FSO	1	Manufacturer	accessdata.fda.gov
Plugger, Root Canal, Endodontic	EKR	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tester, Pulp	EAT	2	Manufacturer	accessdata.fda.gov
Unit, Operative Dental, Accessories	NRD	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 13, 2025	K242317	Integrated Endo System (Meet Endo-II)	ELC	Substantially Equivalent	Denjoy Dental Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 13, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.