Manufacturer registered with FDA
Shenzhen Balinda Technology Co.,Ltd
Shenzhen, China. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Shenzhen Balinda 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 | Shenzhen Balinda Technology Co.,Ltd | 10 device types | — | Below |
| South Korea | MFDS | Manufacturer | Shenzhen Balinda Technology Co., LtdShenzhen Balinda Technology Co., Ltd. · shenzhen balinda technology co., ltd. | 3 | 2020–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shenzhen Balinda Technology Co., Ltd | 2 | — | 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 Shenzhen Balinda 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Aligner Retainer Case/Dental Retainer Case/Orthodontic Mouthguard Case/ Denture Retainer Box | 2024 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Teeth Whitening Light/Teeth Whitening Device | 2021 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Nozzle Tips for water flosserOral Irrigator | 2017 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Denture Cleaning Tablet, Denture Cleanser | 2024 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Dental Scaler/Tartar Remover/Plaque Remover | 2023 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric ToothbrushToothbrush CaseToothbrush Head | 2017 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | Ultrasonic Cleaner/Ultrasonic Retainer Cleaner/Ultrasonic Denture Cleaner | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental Floss | 2018 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Teeth Whitening Kit/Teeth Whitening Pen/Teeth Whitening Gel//Teeth Whitening StripsTeeth Whitening Powder/Teeth whitening foam | 2021 |
| Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1 | — | Maker | Toothbrush Sterilizer/Toothbrush Sanitizer/UV Sanitizer For Toothbrushes | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN BALINDA TECHNOLOGY CO.,LTDFDA reg. 3012896103 | Shenzhen Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056420). 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.