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FDA 510(k)

CAD/CAMouflage Milling Block

K 號：K162537 · 2016-11-16

申請人Prismatik Dentalcraft, Inc.
決定日期2016-11-16
產品代碼EBF
諮詢委員會DE
決定Substantially Equivalent

器材摘要

CAD/CAMouflage Milling Block is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K162537. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CAD/CAMouflage Milling Block?

CAD/CAMouflage Milling Block is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K162537.

When did CAD/CAMouflage Milling Block receive FDA 510(k) clearance?

CAD/CAMouflage Milling Block received FDA 510(k) clearance on 2016-11-16, under 510(k) number K162537.

Who is the listed applicant for CAD/CAMouflage Milling Block?

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

What is the FDA product code for CAD/CAMouflage Milling Block?

The FDA product code for CAD/CAMouflage Milling Block is EBF.

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相關器械（代碼：EBF）

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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