Manufacturer registered with FDA
Jiangxi Dentalbright Technology Co., Ltd
Jiujiang City, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 31
- 510(k) clearances
- 0as applicant
- Markets registered in
- 616 registrations outside the US
- Establishments
- 1China
Registered in 6 markets
Where regulators' registries name Jiangxi Dentalbright Technology Co., Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Jiangxi Dentalbright Technology Co., Ltd | 9 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Jiangxi Dentalbright Technology Co.,Ltd | 8 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Jiangxi Dentalbright Technology Co., Ltd. | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Jiangxi Dentalbright Technology Co., LtdJiangxi Dentalbright Technology Co., Ltd. | 2 | 2025–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | JIANGXI DENTAL BRIGHT TECHNOLOGY CO., LTD | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Jiangxi Dentalbright Technology Co.,Ltd, | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Jiangxi Dentalbright Technology Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Plusma Light; Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light;ProLite LED Teeth Whitening Device, Wireless Dental InstrumentSmart 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 LightTeeth Whitening Mini Light; Mini Light 1led/5led;Teeth Whitening Light 8led/16led; | 2016 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Denture Cleansing Tablet, Aligner Cleaner | 2017 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Teeth Wipes, Brush Ups, Finger Brush, Oral Brush Ups, Bamboo toothbrush, Plastic toothbrush,toothbrush, bamboo toothbrush, Travel Kit Toothbrush & Toothpaste tablets/(refill) | 2016 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Teeth Protector/ Mouth GuardThermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray | 2016 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | 2016 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Dental Impression Material | 2021 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric Toothbrush, Sonic Toothbrush, Electric Led Toothbrush, Sonic Led Toothbrush | 2016 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental Floss | 2023 |
| Dental Stain EraserMAU · Class 1 | — | Maker | BE LUCENT NHpro Enamel Care; BE LUCENT HA5 Gum Serumcharcoal teeth whitening powder,coconut oil pulling;coconut oil sachet, BE LUCENT Teeth Whitening PenDissolving StripsDual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe GelImmune Support Serum; Serum DuoOral Spray; Teeth Whitening Led Kit; Bleachy Teeth Whitening kit; Bleachy Teeth Whitening Led KitRemineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit/Teeth Whitening System;SAKYPRORAL Precision Teeth Whitening PenSAYCHEESE Teeth Whitening KitTeeth Bleaching System/Teeth Bleaching Kit/Teeth Whitening Strips/Double Elastic Gel Strips/Dry Strips 7 moreTeeth Whitening Essenceteeth whitening foamTeeth Whitening Pen/Bleaching Pen/Teeth Whitener/Teeth Whitening Gel 3ml/5ml/10ml/PROFESSIONAL WHITENING GELteeth whitening powder, Stain Prevention, Preventive WhiteningtripsPearlSmile Teeth Whitening Kit; Charcoal Teeth Whitening StripsV34 Colour Corrector; V34 Colour Corrector Foam; NHpro Enamel Care; HA5 Hyaluronic SerumXquisite Smile Teeth Whitening Kit | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Jiangxi Dentalbright Technology Co., Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Nanchang Dental Bright Technology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Jul 2021 | K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTDFDA reg. 3012041047 | Jiujiang City Jiangxi, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052165). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.