Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012041047

FEI Number

3012041047

Entity Name

JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD

City/State/Country

Jiujiang City Jiangxi, CN

Establishment Address

Makou industrial park, Yongxiu County, Jiujiang City Jiangxi 330300, CN

Establishment Type(s)

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

Owner / Operator

Jiangxi Dentalbright Technology Co., Ltd (Owner Number: 10052165)

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

dental impression material Teeth Wipes, Brush Ups, Finger Brush, Oral Brush Ups, Bamboo toothbrush, Plastic toothbrush, toothbrush, bamboo toothbrush, Travel Kit Toothbrush & Toothpaste tablets/(refill) Dental Impression Material Plastic Glasses Isolation Mask; Face Mask denture adhesive cream; denture adhesive powder Dental Floss Plusma Light; Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light; ProLite LED Teeth Whitening Device, Wireless Dental Instrument Teeth Whitening Mini Light; Mini Light 1led/5led;Teeth Whitening Light 8led/16led; Smart Teeth Whitening Device; Smart Teeth Whitening Light; Teeth Whitening Lamp; Teeth Whitening Accelerator; Teeth whitening Led Light 8led/16led; Teeth Whitening Mouth Tray Led Light; Teeth Whitening Mouth Tray Light Denture Cleansing Tablet, Aligner Cleaner Electric Toothbrush, Sonic Toothbrush, Electric Led Toothbrush, Sonic Led Toothbrush Teeth Whitening Pen/Bleaching Pen/Teeth Whitener/Teeth Whitening Gel 3ml/5ml/10ml/PROFESSIONAL WHITENING GEL Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel Teeth Bleaching System/Teeth Bleaching Kit/Teeth Whitening Strips/Double Elastic Gel Strips/Dry Strips teeth whitening powder, Stain Prevention, Preventive Whitening Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit/Teeth Whitening System; charcoal teeth whitening powder,coconut oil pulling;coconut oil sachet, BE LUCENT Teeth Whitening Pen Dissolving Strips teeth whitening foam tripsPearlSmile Teeth Whitening Kit; Charcoal Teeth Whitening Strips SAYCHEESE Teeth Whitening Kit Teeth Whitening Essence Xquisite Smile Teeth Whitening Kit V34 Colour Corrector; V34 Colour Corrector Foam; NHpro Enamel Care; HA5 Hyaluronic Serum Immune Support Serum; Serum Duo Oral Spray; Teeth Whitening Led Kit; Bleachy Teeth Whitening kit; Bleachy Teeth Whitening Led Kit BE LUCENT NHpro Enamel Care; BE LUCENT HA5 Gum Serum Anti Snore Mouth Piece/Snoring Stopper/Anti Snore Mouth Tray/Stop Snoring Solution/Anti Snore Kit/Stop Snoring Device Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel Stop Snoring Chin Strap/Anti Snore Jaw Supporter/Stop Snoring Solution/Anti Snore Belt/Chin Strap Belt Cheek Retractor/Mouth Opener/Lip Retractor, Silicone Cheek Retractor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2019-05-15
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2016-06-23
ELW	Material, Impression	Dental	Class 2	872.3660	2021-07-29
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2023-06-15
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-11
KOT	Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium	Dental	Class 1	872.3490	2019-10-28
JES	Floss, Dental	Dental	Class 1	872.6390	2023-07-10
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2016-06-23
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2017-02-09
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2016-12-09
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2016-06-23
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2016-06-23
EIE	Dam, Rubber	Dental	Class 1	872.6300	2016-06-23
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2016-06-23
EIG	Retractor, All Types	Dental	Class 1	872.4565	2016-06-23

Official Correspondent

Justin Qin

US Agent Details

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

Related Public Records

Same Entity

Jiangxi Dentalbright 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K952614	Dentsply Intl.	JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL	1996-08-13
K884357	Precision Dynamics Corp.	PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM	1988-11-01
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

Similar Registrations

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3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3003169405	MONITEX INDUSTRIAL CO., LTD.	SAN-CHUNG CITY Taipei, TW
9680845	SDS de Mexico S. de R.L. de C.V.	MEXICALI, B.C. C.P. Baja California, MX
3008770655	BEYES DENTAL INC	Toronto Ontario, CA
1420052	BISCO, INC.	Schaumburg, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012041047. Last updated year: 2026. Please use registration number 3012041047 when referencing this establishment in official correspondence.