Hunan Vsmile Biotechnology Co., Ltd.

Manufacturer and brand owner in Changsha, Hunan, China. 6 device types, 2 products catalogued, 2 clearances.

Registry build 21.09.26

Hunan Vsmile Biotechnology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Powder, Porcelain, Wax, Dental, Intraoral and 4 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.

6device types registered with the FDA
2products catalogued under its own name
2510(k) clearances

Registration

FDA registration record for Hunan Vsmile Biotechnology Co., Ltd.
Registered name HUNAN VSMILE BIOTECHNOLOGY CO.,LTD
Status Registered
Registration expires 2026
Registration number 3022068322
FEI number 3022068322
DUNS 553229067
Establishment type Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter

Chinese Registration

Chinese company register details for Hunan Vsmile Biotechnology Co., Ltd.
Chinese legal name 湖南为思迈生物科技有限公司
Source customs registration record

Location

Address of Hunan Vsmile Biotechnology Co., Ltd.
City Changsha
Province Hunan
Address Building A4 No. 2450, Yuelu West Avenue,Changsha Hi-tech Development District
Postal code 410000
Country China

What It Makes

Device types Hunan Vsmile Biotechnology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Crown And Bridge, Temporary, Resin Class 2 Removable resin, Acetal Flexible PMMA Block, PMMA Block 2022 13
Mouthguard, Prescription Class U Flexible Block 2022 6
Powder, Porcelain Class 2 Dental Glass Ceramics Blocks (HT, LT, MT), Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Dithilicate Glass Block 2022 33
Resin, Denture, Relining, Repairing, Rebasing Class 2 Flexible Block 2022 14
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations Class 2 Intraoral Scanner, VLS100 2025 36
Wax, Dental, Intraoral Class 1 wax disc 2022 55

Own-Brand Listings

Devices catalogued by Hunan Vsmile Biotechnology Co., Ltd.
Product Code Catalogue numbers
Vsmilehappyzir Dental Zirconia Blank &Dental Zirconia Pre-Shaded Blank EIH 12
Dental Glass Ceramics Blocks EIH 12

Clearances

2 clearances name Hunan Vsmile Biotechnology Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming Hunan Vsmile Biotechnology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K242407 2024-11-13 EIH Traditional This company
K221242 2022-07-29 EIH Traditional This company
K213994 2022-03-04 EBI Traditional Shandong Huge Dental Material Corporation
K192231 2020-07-08 EIH Traditional Aidite (Qinhuangdao) Technology Co., Ltd.
K141421 2015-02-09 EBG Abbreviated Rizhao Huge Dental Industry Co., Ltd.

From the Company

Published by the company on its own website, not by the FDA.

Information published by Hunan Vsmile Biotechnology Co., Ltd.
Main products Zirconia blocks, CAD/CAM milling machines, Sintering furnaces, PMMA discs, Dental materials
Certifications CE, FDA, ISO13485
Export markets 120+ countries
OEM and ODM Offered

Nearby Manufacturers

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer