Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008590661

FEI Number

3008590661

Entity Name

DENJOY DENTAL CO., LTD

City/State/Country

Changsha city Hunan, CN

Establishment Address

F4, A4 Bld, Lugu Medical Device Park, No. 229 Guyuan Road,, Changsha city Hunan 410205, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

DENJOY DENTAL CO., LTD (Owner Number: 10034843)

Owner / Operator Contact Address

F4, A4 Bld, Lugu Medical Device Park, No. 229 Guyuan Road, Changsha city, CN-HN 410205, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Suction Unit Root Canal Instruments Kit RETRACTOR LED WHITENING LIGHT CORDLESS GUTTA PERCHA OBTURATION SYSTEM, HAND PLUGGER,CORDLESS GUTTA PERCHA OBTURATION PEN GY-DP Gutta Percha Obturation System Integrated Endo System (Meet Endo-II) INTRAORAL CAMERA ENDO MOTOR,ENDO TREATMENT INSTRUMENT, LOW-VOLTAGE ELECTRIC MOTOR ENDO HAND FILE HAND FILE, ROTARY FILE Rotary File,K-File,H-File,K-Reamer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2022-01-04
NYC	Dental Prophylaxis Kit	Dental	Class 1	872.4565	2022-01-04
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2011-02-16
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2011-02-16
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2016-09-21
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2025-02-16
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-02-16
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2025-02-16
FTS	Camera, Cine, Endoscopic, With Audio	General, Plastic Surgery	Class 1	878.4160	2011-02-16
KIJ	Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2011-02-16
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2014-12-05
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2023-11-09

Official Correspondent

Sheng Zhong

US Agent Details

Jason Zhou Email: ShamrockIE49@hotmail.com Phone: (626) 6325067

Related Public Records

Same Entity

DENJOY DENTAL CO., LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K933337	R & D Batteries, Inc.	R AND D BATTERY REPLACEMENT	1994-04-05
K873766	Bowen & Company, Inc.	STERNAL POWER AWL	1988-11-14

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008590661. Last updated year: 2026. Please use registration number 3008590661 when referencing this establishment in official correspondence.