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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 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 2024-10-02 under 510(k) 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. The listed applicant is Liaoning Upcera Co., Ltd.. The 510(k) number is K240153.

When did Ceramic Etchant (HF-5 and HF-9) receive FDA 510(k) clearance?

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

Who is the listed applicant for Ceramic Etchant (HF-5 and HF-9)?

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 Ceramic Etchant (HF-5 and HF-9)?

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

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 SeriesK231687Gradual Dental Zirconia BlankK181167Upcera Glaze Paste, Glaze Powder, and Glaze LiquidK162323Tooth Shade Resin Material

Related Devices (Code: KLE)

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.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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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