FDA 510(k)

IPS e.max 鑫瓷

K 號：K253953 · 2026-03-10

決定日期2026-03-10

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

IPS e.max Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2026-03-10 under 510(k) number K253953. 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 IPS e.max Zirconia?

IPS e.max Zirconia is a medical device that received FDA 510(k) clearance on 2026-03-10. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K253953.

When did IPS e.max Zirconia receive FDA 510(k) clearance?

IPS e.max Zirconia received FDA 510(k) clearance on 2026-03-10, under 510(k) number K253953.

Who is the listed applicant for IPS e.max Zirconia?

The FDA 510(k) record lists Ivoclar Vivadent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPS e.max Zirconia?

The FDA product code for IPS e.max Zirconia is EIH.

其他以 Ivoclar Vivadent, Inc. 為申請人之記錄

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相關器械（代碼：EIH）

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