Jiangxi Dentalbright Technology Co., Ltd.
Manufacturer and brand owner in Jiujiang, Jiangxi, China. 12 device types, 6 products catalogued.
Jiangxi Dentalbright Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Dam, Rubber, Floss, Dental and 10 other device types. 6 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2016.
12device types registered with the FDA
6products catalogued under its own name
Registration
| Registered name | JIANGXI DENTALBRIGHT TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012041047 |
| FEI number | 3012041047 |
| DUNS | 544503502 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Jiujiang |
|---|---|
| Province | Jiangxi |
| Address | Makou industrial park, Yongxiu County |
| Postal code | 330300 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Adaptor, Hygiene | Class 1 | Disinfectant box for denture, Toothbrush sterilization box | 2021 | 193 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Vitamin E Swab, Bent Tips | 2016 | 186 |
| Cleanser, Denture, Over The Counter | Class 1 | Denture Cleansing Tablet, Aligner Cleaner | 2017 | 34 |
| Dam, Rubber | Class 1 | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | 2016 | 23 |
| Eraser, Dental Stain | Class 1 | Teeth Whitening Pen/Bleaching Pen/Teeth Whitener/Teeth Whitening Gel 3ml/5ml/10ml/PROFESSIONAL WHITENING GEL, Teeth Bleaching System/Teeth Bleaching Kit/Teeth Whitening Strips/Double Elastic Gel Strips/Dry Strips, Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel, Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit/Teeth Whitening System;, teeth whitening powder, Stain Prevention, Preventive Whitening, charcoal teeth whitening powder,coconut oil pulling;coconut oil sachet, BE LUCENT Teeth Whitening Pen and 10 more | 2016 | 33 |
| Floss, Dental | Class 1 | Dental Floss | 2023 | 151 |
| Heat Source For Bleaching Teeth | Class 1 | Smart Teeth Whitening Device; Smart Teeth Whitening Light; Teeth Whitening Lamp; Teeth Whitening Accelerator;, Teeth Whitening Mini Light; Mini Light 1led/5led;Teeth Whitening Light 8led/16led;, Plusma Light; Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light;, Teeth whitening Led Light 8led/16led; Teeth Whitening Mouth Tray Led Light; Teeth Whitening Mouth Tray Light, ProLite LED Teeth Whitening Device, Wireless Dental Instrument | 2016 | 56 |
| Material, Impression | Class 2 | Dental Impression Material | 2021 | 6 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | Plastic Glasses | 2023 | 384 |
| Toothbrush, Manual | Class 1 | Teeth Wipes, Brush Ups, Finger Brush, Oral Brush Ups, Bamboo toothbrush, Plastic toothbrush,, toothbrush, bamboo toothbrush, Travel Kit Toothbrush & Toothpaste tablets/(refill) | 2016 | 244 |
| Toothbrush, Powered | Class 1 | Electric Toothbrush, Sonic Toothbrush, Electric Led Toothbrush, Sonic Led Toothbrush | 2016 | 191 |
| Tray, Impression, Preformed | Class 1 | Thermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray, Teeth Protector/ Mouth Guard | 2016 | 73 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| GlorySmile | MAU | 28 |
| GlorySmile | ELW | 4 |
| Glorysmile | EID | 1 |
| Daniel | MAU | 1 |
| Non | MAU | 1 |
| Dr.DENT.co | MAU | 1 |
Clearances
No clearance names Jiangxi Dentalbright Technology Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K211489 | 2021-07-28 | ELW | Traditional | Nanchang Dental Bright Technology Co., Ltd. |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Jiujiang Huada Medical Dressing Co., Ltd. | 18 |
| Jiangxi Ushine Bright Medical Co., Ltd. | 17 |
| priMED Jiujiang Medical Products Manufacturing Co., Ltd. | 7 |
| Jiujiang Jiebao Medicine Equipment Co., Ltd. | 4 |
| Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | 3 |
| Medwell Medical Products Co., Ltd. | 3 |
| Jiujiang Meite Jewelry Co..Ltd. | 3 |
| Maggie FAR East (Jiujiang) Infant Products Co., Ltd. | 2 |
| Jiangxi Rekonova Dental Materials Co., Ltd. | 1 |
| DE Corematrix Co., Ltd. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.