Manufacturer registered with FDA
Hangzhou PengWu Medical Equipment Co.,Ltd
Hangzhou, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 413 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Hangzhou PengWu Medical Equipment 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 | Hangzhou PengWu Medical Equipment Co.,Ltd | 9 device types | — | Below |
| South Korea | MFDS | Manufacturer | Hangzhou PengWu Medical Equipment Co.,LtdHANGZHOU PENGWU MEDICAL EQUIPMENT CO.,LTD | 9 | 2020–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HANGZHOU PENGWU MEDICAL EQUIPMENT CO.,LTDHangzhou Pengwu Medical Equipment Co., Ltd. | 3 | 2019–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | HANGZHOU PENGWU MEDICAL EQUIPMENT CO. LTD. | 1 | 2026–2026 | 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 Hangzhou PengWu Medical Equipment 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 | SmileStreamSolutions / PW Ortho | 2018 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | SmileStreamSolutions / PW Ortho | 2018 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | SmileStreamSolutions / PW Ortho | 2018 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | SmileStreamSolutions / PW Ortho | 2018 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | SmileStreamSolutions / PW Ortho | 2018 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | SmileStreamSolutions / PW Ortho | 2019 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | SmileStreamSolutions / PW Ortho | 2018 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | SmileStreamSolutions / PW Ortho | 2018 |
| FacebowKCR · Class 1 | Articulators & facebows | Maker | SmileStreamSolutions / PW Ortho | 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 |
|---|---|---|
| HANGZHOU PENGWU MEDICAL EQUIPMENT CO.,LTDFDA reg. 3013519244 | Hangzhou Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058484). 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.