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FDA 510(k)

Pre-Sintered Zirconia Coloring Liquid

K-Number: K232682 · 2024-03-19

ApplicantChengdu Besmile Medical Technology Co., Ltd.
Decision Date2024-03-19
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Pre-Sintered Zirconia Coloring Liquid 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 2024-03-19 under 510(k) number K232682. 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 Pre-Sintered Zirconia Coloring Liquid?

Pre-Sintered Zirconia Coloring Liquid is a medical device that received FDA 510(k) clearance on 2024-03-19. The listed applicant is Chengdu Besmile Medical Technology Co., Ltd.. The 510(k) number is K232682.

When did Pre-Sintered Zirconia Coloring Liquid receive FDA 510(k) clearance?

Pre-Sintered Zirconia Coloring Liquid received FDA 510(k) clearance on 2024-03-19, under 510(k) number K232682.

Who is the listed applicant for Pre-Sintered Zirconia Coloring Liquid?

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 Pre-Sintered Zirconia Coloring Liquid?

The FDA product code for Pre-Sintered Zirconia Coloring Liquid is EIH.

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 ScrewK232676Dental Porcelain PowderK232673Dental Glass Ceramics

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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