Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015287618

FEI Number

3015287618

Entity Name

HEYUAN HEY WHITE TECHNOLOGY CO., LTD.

City/State/Country

Heyuan Guangdong, CN

Establishment Address

3rd Road, Linjiang Industrial Park, Zijin County, Heyuan Guangdong 517000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Heyuan Hey White Technology Co., Ltd. (Owner Number: 10059803)

Owner / Operator Contact Address

3rd Road, Linjiang Industrial Park, Zijin County, Heyuan, CN-GD 517000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Professional Shade Guide Oral Device YLX-307i, Teeth Whitening Device, teeth whitening vibration device Red light therapy device Light therapy toothbrush Optical Whitening Toothbrush Vitamin E Swab check retractor Anti-snore mouth guard Mouth Tray; Tray Case Children toothbrush Finger brush Gum protector Gum health serum Bib Table; Egg chair Goggles

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2019-02-25
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2019-02-25
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2019-02-25
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2019-02-25
EIG	Retractor, All Types	Dental	Class 1	872.4565	2019-02-25
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2019-02-25
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2020-10-23
EIE	Dam, Rubber	Dental	Class 1	872.6300	2019-02-25
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2019-12-21
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2024-12-20
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2024-12-20

Official Correspondent

Jieyan He

US Agent Details

Fanny Zhao Business: J& F Technology Service Email: info@jf-yiliao.com Phone: (909) 5100201

Related Public Records

Same Entity

Heyuan Hey White Technology 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
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02

Similar Registrations

Registration Number	Establishment Name	Location
3016564992	DENTAC LLC	North Miami, FL, US
3042623520	ZINGO DIGITAL DENTAL LAB LLC	Mount Prospect, IL, US
3010253209	ENTA B.V.	Bergen op Zoom Noord-Brabant, NL
3007740664	Shenzhen Jiahong Dental Technology Co., Ltd	Shenzhen Guangdong, CN
3002727993	GEBDI DENTAL PRODUCTS GMBH	Engen Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015287618. Last updated year: 2026. Please use registration number 3015287618 when referencing this establishment in official correspondence.