FDA 510(k)

逐漸牙齒氧化鎂鋁陶瓷空白 - GT(F) P1、GT(F) P2 及 SP 系列

K 號：K253973 · 2026-01-09

決定日期2026-01-09

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Liaoning Upcera Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253380“FLNT 基座”及“FLNT 溫度”K240153陶瓷蝕刻劑 (HF-5 和 HF-9)K231687逐漸牙齒氧化鎂鋁陶瓷空白 K181167Upcera 銘光膠膠漿、銘光膠粉末及銘光膠液 K162323牙色树脂材質

相關器械（代碼：EIH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262074任何-錫科斯Mediclus Co., Ltd.K262239Obsidian® 压克力壓克力超過鎂鋁Prismatik Dentalcraft, Inc.K261046牙醫用氧化鋁陶瓷空白片及上色液Hunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy陶瓷染色及釉料Zima International Inc., dba Dandy K260918佐立隆尼士Amann Girrbach AG K260859羅塞塔SM，羅塞塔SPHass Corp.

官方來源

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