Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023895623

FEI Number

3023895623

Entity Name

Jiangxi Ushine Bright Medical Co., Ltd.

City/State/Country

Jiujiang City Jiangxi, CN

Establishment Address

Makou Industrial Park, Yongxiu County, Jiujiang City Jiangxi 330300, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jiangxi Ushine Bright Medical Co., Ltd. (Owner Number: 10089595)

Owner / Operator Contact Address

Makou industrial park, Yongxiu County, Jiujiang City, CN-JX 330300, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Gum Dam/ Gum Protetcor/Gingival Barrier Plastic Glasses Stop Snoring Chin Strap/Anti Snore Jaw Supporter/Anti Snore Belt/ Chin Strap Belt Electric Toothbrush/ Sonic Toothbrush/ Electric Led Toothbrush/ Sonic Led Toothbrush Cheek Retractor/Mouth Opener Denture Cleansing Tablet/Aligner Cleaner Teeth Protector Thermoplastic Mouth Tray/ Mouth Piece/ Teeth Whitening Mouth Tray/ Foam Strip Mouth Tray/ Gel Prefilled Mouth Tray Dental Floss Oral irrigator Denture Adhesive Cream; Denture Adhesive Powder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIE	Dam, Rubber	Dental	Class 1	872.6300	2023-12-20
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2023-12-20
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2023-12-20
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2023-12-20
EIG	Retractor, All Types	Dental	Class 1	872.4565	2023-12-20
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2023-12-20
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2023-12-20
JES	Floss, Dental	Dental	Class 1	872.6390	2023-12-20
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2024-09-13
KOT	Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	Dental	Class 1	872.3490	2023-12-20

Official Correspondent

Junyuan Qin

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Jiangxi Ushine Bright Medical 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
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K884357	Precision Dynamics Corp.	PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM	1988-11-01

Similar Registrations

Registration Number	Establishment Name	Location
3025307990	HDI INC.	Seongnam-si Gyeonggi, KR
3008475975	GLO Science, Inc.	Garden Grove, CA, US
3009420946	HUANGHUA PROMISEE DENTAL CO., LTD	Huanghua Hebei, CN
1424442	PRIME DENTAL MANUFACTURING, INC.	CHICAGO, IL, US
3038632739	TF NEW MATERIAL SCI AND TEC CO.,LTD	Huainan Anhui, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023895623. Last updated year: 2026. Please use registration number 3023895623 when referencing this establishment in official correspondence.