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Hunan Vsmile Biotechnology Co.,ltd: FDA-registered device maker in Changsha Hunan, China, 5 510(k) clearances

Name: Hunan Vsmile Biotechnology Co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Hunan Vsmile Biotechnology Co.,ltd is registered with the FDA (registration 3022068322) in Changsha Hunan, China. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 13, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3022068322
Address: Building A4 No. 2450, Yuelu West Avenue,Changsha Hi-tech Development District, Changsha Hunan, China, 410000
Owner or operator: Hunan Vsmile Biotechnology Co.,Ltd (10085833)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: August 18, 2022
Registered through: 2026
Brand names listed: Acetal Flexible PMMA Block, Dental Glass Ceramics Blocks (HT, LT, MT), Dithilicate Glass Block, Flexible Block, Intraoral Scanner, VLS100, PMMA Block, Removable resin, Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank and more

Devices it lists

Device	Product code	Class	Role	Source
Crown And Bridge, Temporary, Resin	EBG	2	Repackager or relabeler	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Repackager or relabeler	accessdata.fda.gov
Powder, Porcelain	EIH	2	Exporter to the US, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Repackager or relabeler	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Manufacturer	accessdata.fda.gov
Wax, Dental, Intraoral	EGD	1	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 13, 2024	K242407	Dental Glass Ceramics Blocks (HT, LT, MT)	EIH	Substantially Equivalent	Hunan Vsmile Biotechnology Co., Ltd.	accessdata.fda.gov
July 29, 2022	K221242	Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank	EIH	Substantially Equivalent	Hunan Vsmile Biotechnology Co., Ltd.	accessdata.fda.gov
March 4, 2022	K213994	Flexible Block	EBI	Substantially Equivalent	Shandong Huge Dental Material Corporation	accessdata.fda.gov
July 8, 2020	K192231	Dental Glass Ceramics Blocks	EIH	Substantially Equivalent	Aidite (Qinhuangdao) Technology Co., Ltd.	accessdata.fda.gov
February 9, 2015	K141421	PMMA BLOCK	EBG	Substantially Equivalent	Rizhao Huge Dental Industry Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated November 13, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.