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FDA 510(k)

Ceramic Denture Zirconia Ceramics Block

K-Number: K181816 · 2018-11-29

ApplicantQinhuangdao Silide Ceramic Technology Co., Ltd.
Decision Date2018-11-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ceramic Denture Zirconia Ceramics Block is the device name listed in this FDA 510(k) record. The listed applicant is Qinhuangdao Silide Ceramic Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-11-29 under 510(k) number K181816. 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 Ceramic Denture Zirconia Ceramics Block?

Ceramic Denture Zirconia Ceramics Block is a medical device that received FDA 510(k) clearance on 2018-11-29. The listed applicant is Qinhuangdao Silide Ceramic Technology Co., Ltd.. The 510(k) number is K181816.

When did Ceramic Denture Zirconia Ceramics Block receive FDA 510(k) clearance?

Ceramic Denture Zirconia Ceramics Block received FDA 510(k) clearance on 2018-11-29, under 510(k) number K181816.

Who is the listed applicant for Ceramic Denture Zirconia Ceramics Block?

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

What is the FDA product code for Ceramic Denture Zirconia Ceramics Block?

The FDA product code for Ceramic Denture Zirconia Ceramics Block is EIH.

Related Clinical Trials

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.

NCT07633574Additive vs Subtractive Manufacturing for Endocrown Fabrication: A 24-Month RCTNOT_YET_RECRUITING

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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