Manufacturer registered with FDA
Hunan Vsmile Biotechnology Co.,Ltd
Changsha, China. Lists 5 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 9
- 510(k) clearances
- 22022–2024
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Hunan Vsmile 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 | Hunan Vsmile Biotechnology Co.,Ltd | 2 clearances | 2022–2024 | Below |
| Brazil | ANVISA | Manufacturer | HUNAN VSMILE BIOTECHNOLOGY CO., LTD | 2 | 2020–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hunan Vsmile Biotechnology Co.,Ltd | 2 | — | 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 Hunan Vsmile 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental Glass Ceramics Blocks (HT, LT, MT)Dithilicate Glass BlockVsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2022 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | Acetal Flexible PMMA BlockPMMA BlockRemovable resin | 2022 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | Flexible Block | 2022 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | wax disc | 2022 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Intraoral Scanner, VLS100 | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Hunan Vsmile Biotechnology Co.,Ltd as the applicant.
Also lists devices cleared under other names
Hunan Vsmile Biotechnology Co.,Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Shandong Huge Dental Material Corporation (1), Aidite (Qinhuangdao) Technology Co., Ltd (1), Rizhao Huge Dental Industry Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 4 Mar 2022 | K213994 | Flexible Block | Shandong Huge Dental Material Corporation | EBI Rebasing Repairing Relining Denture Resin |
| 8 Jul 2020 | K192231 | Dental Glass Ceramics Blocks | Aidite (Qinhuangdao) Technology Co., Ltd | EIH Porcelain Powder |
| 9 Feb 2015 | K141421 | PMMA BLOCK | Rizhao Huge Dental Industry Co., Ltd. | EBG Resin Temporary Crown and Bridge |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HUNAN VSMILE BIOTECHNOLOGY CO.,LTDFDA reg. 3022068322 | Changsha Hunan, China | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085833). 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.