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FDA 510(k)

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

K-Number: K221242 · 2022-07-29

ApplicantHunan Vsmile Biotechnology Co., Ltd.
Decision Date2022-07-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vsmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K221242. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Hunan Vsmile Biotechnology Co., Ltd.. The 510(k) number is K221242.

When did Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank receive FDA 510(k) clearance?

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2022-07-29, under 510(k) number K221242.

Who is the listed applicant for Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA 510(k) record lists Hunan Vsmile Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA product code for Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.

Other records listing Hunan Vsmile Biotechnology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242407Dental Glass Ceramics Blocks (HT, LT, MT)

Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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