FDA 510(k)

Gradual 钛酸锆牙冠空白 - GT(F) P1，GT(F) P2 和 SP 系列

K号: K253973 · 2026-01-09

决定日期2026-01-09

产品代码EIH

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决定实质等同

器械摘要

Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series 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 2026-01-09 under 510(k) number K253973. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

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. The listed applicant is Liaoning Upcera Co., Ltd.. The 510(k) number is K253973.

When did Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series receive FDA 510(k) clearance?

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

Who is the listed applicant for Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series?

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 - 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.

列明Liaoning Upcera Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253380“FLNT 基础”和“FLNT 临时”K240153陶瓷蚀刻剂（HF-5 和 HF-9）K231687Gradual 钛酸锆牙冠空白 K181167Upcera 釉料膏，釉料粉，和釉料液体 K162323牙齿着色树脂材料

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。