Manufacturer registered with FDA
Loyol New Material Suhzou Co.,Ltd
Suzhou, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 211 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Loyol New Material Suhzou 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 | Loyol New Material Suhzou Co.,Ltd | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Loyol New Material Suhzou Co.,Ltd. | 11 | — | 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 Loyol New Material Suhzou 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 |
|---|---|---|---|---|
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Model, Tray, Gingvia Mask, Casting Wax, Study Model, Ortho Model | 2023 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Try-In, Surgical Guide | 2023 |
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 |
|---|---|---|
| Loyol New Material Suhzou Co.,Ltd.FDA reg. 3027520370 | Suzhou Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088148). 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.