Manufacturer registered with FDA
Hangzhou IVISTA Medical Devices Co., Ltd
Hangzhou, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 12024–2024
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Hangzhou IVISTA Medical Devices 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 IVISTA Medical Devices Co., Ltd | 1 clearances | 2024–2024 | Below |
| European Union | EUDAMED | Manufacturer | Hangzhou IVISTA Medical Devices 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 Hangzhou IVISTA Medical Devices 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Zirconia Block | 2024 |
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 IVISTA MEDICAL DEVICES CO., LTDFDA reg. 3030536692 | Hangzhou Zhejiang, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089875). 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.