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FDA 510(k)

Ceramic Etchant (HF-5 and HF-9)

K-Number: K240153 · 2024-10-02

ApplicantLiaoning Upcera Co., Ltd.
Decision Date2024-10-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ceramic Etchant (HF-5 and HF-9) is a medical device manufactured by Liaoning Upcera Co., Ltd.. It received FDA 510(k) clearance on 2024-10-02 under approval number K240153. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceramic Etchant (HF-5 and HF-9)?

Ceramic Etchant (HF-5 and HF-9) is a medical device that received FDA 510(k) clearance on 2024-10-02. It is manufactured by Liaoning Upcera Co., Ltd.. The 510(k) number is K240153.

When was Ceramic Etchant (HF-5 and HF-9) approved by the FDA?

Ceramic Etchant (HF-5 and HF-9) received FDA 510(k) clearance on 2024-10-02, under approval number K240153.

What company makes Ceramic Etchant (HF-5 and HF-9)?

Ceramic Etchant (HF-5 and HF-9) is manufactured by Liaoning Upcera Co., Ltd..

What is the FDA product code for Ceramic Etchant (HF-5 and HF-9)?

The FDA product code for Ceramic Etchant (HF-5 and HF-9) is KLE.

Other Devices by Liaoning Upcera Co., Ltd.

K162323Tooth Shade Resin Material K181167Upcera Glaze Paste, Glaze Powder, and Glaze Liquid K231687Gradual Dental Zirconia Blank K253380“FLNT Base” and “FLNT Temp” K253973Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series

Related Devices (Code: KLE)

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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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