Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022068322

FEI Number

3022068322

Entity Name

HUNAN VSMILE BIOTECHNOLOGY CO.,LTD

City/State/Country

Changsha Hunan, CN

Establishment Address

Building A4 No. 2450, Yuelu West Avenue,Changsha Hi-tech Development District, Changsha Hunan 410000, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Hunan Vsmile Biotechnology Co.,Ltd (Owner Number: 10085833)

Owner / Operator Contact Address

Building A4 No. 2450, Yuelu West Avenue, Changsha Hi-tech Development District, Changsha, CN-HN 410000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221242

PMA Number

N/A

All Registered Proprietary Names

Flexible Block Removable resin Dithilicate Glass Block wax disc Flexible Block Intraoral Scanner, VLS100 Dental Glass Ceramics Blocks (HT, LT, MT) Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2022-12-13
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2022-12-13
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2022-12-13
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2022-12-13
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2022-12-13
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2025-06-25
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2024-11-25
EIH	Powder, Porcelain	Dental	Class 2	872.6660	2022-08-18

Official Correspondent

Xiaomi Tang

US Agent Details

Jason Zhou Email: ShamrockIE49@hotmail.com Phone: (626) 6325067

Related Public Records

Same Entity

Hunan Vsmile Biotechnology Co.,Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K143656	H.C. Starck Ceramics GmbH	StarCeram® Z-Nature, StarCeram® Z-Smile	2015-07-09
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Z-0018-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Z-0019-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Z-0020-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Z-0021-2017	Ivoclar Vivadent, Inc.	2	Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain

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3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR
1410097	GC AMERICA INC.	ALSIP, IL, US
3015396763	MGNEWTON LTD.	Gyengsan-si Gyeongbuk, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022068322. Last updated year: 2026. Please use registration number 3022068322 when referencing this establishment in official correspondence.