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FDA 510(k)

Dental Glass Ceramics Blocks (HT, LT, MT)

K-Number: K242407 · 2024-11-13

ApplicantHunan Vsmile Biotechnology Co., Ltd.
Decision Date2024-11-13
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Glass Ceramics Blocks (HT, LT, MT) 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 2024-11-13 under 510(k) number K242407. 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 Dental Glass Ceramics Blocks (HT, LT, MT)?

Dental Glass Ceramics Blocks (HT, LT, MT) is a medical device that received FDA 510(k) clearance on 2024-11-13. The listed applicant is Hunan Vsmile Biotechnology Co., Ltd.. The 510(k) number is K242407.

When did Dental Glass Ceramics Blocks (HT, LT, MT) receive FDA 510(k) clearance?

Dental Glass Ceramics Blocks (HT, LT, MT) received FDA 510(k) clearance on 2024-11-13, under 510(k) number K242407.

Who is the listed applicant for Dental Glass Ceramics Blocks (HT, LT, MT)?

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 Dental Glass Ceramics Blocks (HT, LT, MT)?

The FDA product code for Dental Glass Ceramics Blocks (HT, LT, MT) is EIH.

Related Clinical Trials

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NCT076337173-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal AdaptationACTIVE_NOT_RECRUITING

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.

K221242Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

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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