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FDA 510(k)

Gradual Dental Zirconia Blank

K-Number: K231687 · 2023-09-07

ApplicantLiaoning Upcera Co., Ltd.
Decision Date2023-09-07
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Gradual Dental Zirconia Blank is the device name listed in this FDA 510(k) record. The listed applicant is Liaoning Upcera Co., Ltd.. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K231687. 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 Gradual Dental Zirconia Blank?

Gradual Dental Zirconia Blank is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Liaoning Upcera Co., Ltd.. The 510(k) number is K231687.

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

Gradual Dental Zirconia Blank received FDA 510(k) clearance on 2023-09-07, under 510(k) number K231687.

Who is the listed applicant for Gradual Dental Zirconia Blank?

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

What is the FDA product code for Gradual Dental Zirconia Blank?

The FDA product code for Gradual Dental Zirconia Blank is EIH.

Other records listing Liaoning Upcera 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.

K253380“FLNT Base” and “FLNT Temp”K253973Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP SeriesK240153Ceramic Etchant (HF-5 and HF-9)K181167Upcera Glaze Paste, Glaze Powder, and Glaze LiquidK162323Tooth Shade Resin Material

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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