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FDA 510(k)

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series

K-Number: K253973 · 2026-01-09

ApplicantLiaoning Upcera Co., Ltd.
Decision Date2026-01-09
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series is a medical device manufactured by Liaoning Upcera Co., Ltd.. It received FDA 510(k) clearance on 2026-01-09 under approval number K253973. 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 - GT(F) P1, GT(F) P2, and SP Series?

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series is a medical device that received FDA 510(k) clearance on 2026-01-09. It is manufactured by Liaoning Upcera Co., Ltd.. The 510(k) number is K253973.

When was Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series approved by the FDA?

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series received FDA 510(k) clearance on 2026-01-09, under approval number K253973.

What company makes Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series?

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series is manufactured by Liaoning Upcera Co., Ltd..

What is the FDA product code for Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series?

The FDA product code for Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series is EIH.

Related Clinical Trials

NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING NCT07515937 Occlusal Assessment of Pediatric Mandibular Fractures Managed by 3D-Printed Acrylic Occlusal Cap Splint: A Case Series RECRUITING

Other Devices by Liaoning Upcera Co., Ltd.

K162323Tooth Shade Resin Material K181167Upcera Glaze Paste, Glaze Powder, and Glaze Liquid K231687Gradual Dental Zirconia Blank K240153Ceramic Etchant (HF-5 and HF-9) K253380“FLNT Base” and “FLNT Temp”

Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160203ADAMANT ZIRCONIA DISCAdamant Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, Inc.

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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