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FDA 510(k)

Upcera Glaze Paste, Glaze Powder, and Glaze Liquid

K-Number: K181167 · 2018-09-02

ApplicantLiaoning Upcera Co., Ltd.
Decision Date2018-09-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Upcera Glaze Paste, Glaze Powder, and Glaze Liquid 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 2018-09-02 under 510(k) number K181167. 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 Upcera Glaze Paste, Glaze Powder, and Glaze Liquid?

Upcera Glaze Paste, Glaze Powder, and Glaze Liquid is a medical device that received FDA 510(k) clearance on 2018-09-02. The listed applicant is Liaoning Upcera Co., Ltd.. The 510(k) number is K181167.

When did Upcera Glaze Paste, Glaze Powder, and Glaze Liquid receive FDA 510(k) clearance?

Upcera Glaze Paste, Glaze Powder, and Glaze Liquid received FDA 510(k) clearance on 2018-09-02, under 510(k) number K181167.

Who is the listed applicant for Upcera Glaze Paste, Glaze Powder, and Glaze Liquid?

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 Upcera Glaze Paste, Glaze Powder, and Glaze Liquid?

The FDA product code for Upcera Glaze Paste, Glaze Powder, and Glaze Liquid is EIH.

Other records listing Liaoning Upcera Co., Ltd. as applicant

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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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