Manufacturer registered with FDA
Waterpulse (Jinhua) Biotechnology Co., Ltd
Yiwu City, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Waterpulse (Jinhua) Biotechnology 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 | Waterpulse (Jinhua) Biotechnology Co., Ltd | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Waterpulse (Jinhua) Biotechnology Co., Ltd | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Waterpulse (Jinhua) Biotechnology 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 Waterpulse (Jinhua) Biotechnology 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 |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Unit, Water Flosser, Oral irrigator- Cordless water flosser (V200, V400Plus, V500, V580);Water flosser (V300, V300G, V300R, V360, V600, V600G, V660, V700, V700Plus, V800) | 2018 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric Toothbrush (K3, K5); Sonic Toothbrush (S6, S7, S8, S9) | 2018 |
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 |
|---|---|---|
| Waterpulse (Jinhua) Biotechnology Co., LtdFDA reg. 3014266447 | Yiwu City Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056712). 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.