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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 a medical device manufactured by Hunan Vsmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under approval 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. It is manufactured by Hunan Vsmile Biotechnology Co., Ltd.. The 510(k) number is K221242.

When was Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank approved by the FDA?

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

What company makes Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is manufactured by Hunan Vsmile Biotechnology Co., Ltd..

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.

Related Clinical Trials

NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING

Other Devices by Hunan Vsmile Biotechnology Co., Ltd.

K242407Dental Glass Ceramics Blocks (HT, LT, MT)

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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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