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FDA 510(k)

Dental Glass Ceramics

K-Number: K232673 · 2024-01-23

ApplicantChengdu Besmile Medical Technology Co., Ltd.
Decision Date2024-01-23
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Glass Ceramics is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Besmile Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-23 under 510(k) number K232673. 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?

Dental Glass Ceramics is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Chengdu Besmile Medical Technology Co., Ltd.. The 510(k) number is K232673.

When did Dental Glass Ceramics receive FDA 510(k) clearance?

Dental Glass Ceramics received FDA 510(k) clearance on 2024-01-23, under 510(k) number K232673.

Who is the listed applicant for Dental Glass Ceramics?

The FDA 510(k) record lists Chengdu Besmile Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Glass Ceramics?

The FDA product code for Dental Glass Ceramics 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 Chengdu Besmile Medical Technology 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.

K252286BIORES Dental Implant SystemK242768Customized Abutment and ScrewK232682Pre-Sintered Zirconia Coloring LiquidK232676Dental Porcelain Powder

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

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

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