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FDA 510(k)

Zirconia Dental Ceramics

K-Number: K170894 · 2017-08-01

ApplicantChengdu Besmile Biotechnology Co., Ltd.
Decision Date2017-08-01
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Zirconia Dental Ceramics is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Besmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K170894. 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 Zirconia Dental Ceramics?

Zirconia Dental Ceramics is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Chengdu Besmile Biotechnology Co., Ltd.. The 510(k) number is K170894.

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

Zirconia Dental Ceramics received FDA 510(k) clearance on 2017-08-01, under 510(k) number K170894.

Who is the listed applicant for Zirconia Dental Ceramics?

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

What is the FDA product code for Zirconia Dental Ceramics?

The FDA product code for Zirconia Dental Ceramics is EIH.

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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