Manufacturer registered with FDA
Guangzhou FuZelong Hygiene Material Co Ltd
Conghua, China. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 817 registrations outside the US
- Establishments
- 1China
Registered in 8 markets
Where regulators' registries name Guangzhou FuZelong Hygiene Material 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 | Guangzhou FuZelong Hygiene Material Co Ltd | 1 device types | — | Below |
| Brazil | ANVISA | Manufacturer | GUANGZHOU FUZELONG HYGIENE MATERIAL CO., LTD | 8 | 2013–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | GuangZhou FuZelong Hygiene Material Co., LtdGuangZhou FuZelong Hygiene Material Co., Ltd. · Guangzhou Fuzelong Hygiene Material Co., Ltd. | 3 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Guangzhou FuZelong Hygiene Material Co Ltd | 2 | 2021–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | GUANGZHOU FUZELONG HYGIENE MATERIAL CO., LTD. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | guangzhou fuzelong hygiene material co.,ltd | 1 | 2014–2014 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GUANGZHOU FUZELONG HYGIENE MATERIAL CO., LTD. | 1 | 2019–2019 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Guangzhou Fuzelong Hygiene Material 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 Guangzhou FuZelong Hygiene Material 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 |
|---|---|---|---|---|
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | PUYUAN | 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 |
|---|---|---|
| GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD.FDA reg. 3008559312 | Guangzhou Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033567). 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.