Data / Medical devices / China / Jiangxi Dentalbright Technology Co., Ltd
Jiangxi Dentalbright Technology Co., Ltd: FDA-registered device maker in Jiujiang City Jiangxi, China, 1 510(k) clearance
Jiangxi Dentalbright Technology Co., Ltd is registered with the FDA (registration 3012041047) in Jiujiang City Jiangxi, China. It lists 12 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 28, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012041047
- Address
- Makou industrial park, Yongxiu County, Jiujiang City Jiangxi, China, 330300
- Owner or operator
- Jiangxi Dentalbright Technology Co., Ltd (10052165)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- June 23, 2016
- Registered through
- 2027
- Brand names listed
- BE LUCENT NHpro Enamel Care; BE LUCENT HA5 Gum Serum, Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel, Dental Floss, Dental Impression Material, Denture Cleansing Tablet, Aligner Cleaner, Disinfectant box for denture, Toothbrush sterilization box, Dissolving Strips, Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adaptor, Hygiene | ILS | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cleanser, Denture, Over The Counter | EFT | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Eraser, Dental Stain | MAU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Toothbrush, Powered | JEQ | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 28, 2021 | K211489 | Dental Impression Material | ELW | Substantially Equivalent | Nanchang Dental Bright Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Manual
- All makers of Dam, Rubber
- All makers of Cleanser, Denture, Over The Counter
- All makers of Toothbrush, Powered
- All makers of Eraser, Dental Stain
- All makers of Material, Impression
Updated July 28, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.