Manufacturer registered with FDA
Shenzhen Baotonghui Industrial Co.,Ltd
Shenzhen, China. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Shenzhen Baotonghui Industrial 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 Baotonghui Industrial Co.,Ltd | 10 device types | — | Below |
| South Korea | MFDS | Manufacturer | Shenzhen Baotonghui Industrial Co.,Ltd | 1 | 2025–2025 | 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 Baotonghui Industrial 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 |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Orthodontic accessories | 2022 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Dental tools | 2026 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Water Flosser/Oral Irrigator | 2026 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Interdental brush, Manual toothbrush/Toothbrush head | 2022 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Powered toothbrush/Toothbrush head | 2026 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental floss, Dental Floss Pick, Floss threader | 2022 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Plastic toothpick | 2022 |
| Tongue ScraperLCN · Class 1 | — | Maker | Tongue scraper | 2022 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Teeth whitening products | 2026 |
| Dental Hygiene KitNXZ · Class 1 | — | Maker | Oral care kit | 2026 |
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 BAOTONGHUI INDUSTRIAL CO.,LTDFDA reg. 3019912897 | Shenzhen Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086151). 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.