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FDA 510(k)

K2 齒科陶瓷白經典款；K2 齒科陶瓷透明款；K2 純白極透明款

K 號：K173971 · 2018-11-15

申請人Yeti Dentalprodukte GmbH
決定日期2018-11-15
產品代碼EIH
諮詢委員會DE
決定相當於

器材摘要

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent is the device name listed in this FDA 510(k) record. The listed applicant is Yeti Dentalprodukte GmbH. It received FDA 510(k) clearance on 2018-11-15 under 510(k) number K173971. 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 K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent?

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent is a medical device that received FDA 510(k) clearance on 2018-11-15. The listed applicant is Yeti Dentalprodukte GmbH. The 510(k) number is K173971.

When did K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent receive FDA 510(k) clearance?

K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent received FDA 510(k) clearance on 2018-11-15, under 510(k) number K173971.

Who is the listed applicant for K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent?

The FDA 510(k) record lists Yeti Dentalprodukte GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent?

The FDA product code for K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent is EIH.

相關臨床試驗

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。

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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。

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官方來源

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