FDA 510(k)

山鹿粉紅 CAD/CAM 盤

K 號：K172683 · 2018-01-16

決定日期2018-01-16

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

Yamahachi Pink CAD/CAM Disk is the device name listed in this FDA 510(k) record. The listed applicant is YAMAHACHI DENTAL MFG., Co.. It received FDA 510(k) clearance on 2018-01-16 under 510(k) number K172683. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Yamahachi Pink CAD/CAM Disk?

Yamahachi Pink CAD/CAM Disk is a medical device that received FDA 510(k) clearance on 2018-01-16. The listed applicant is YAMAHACHI DENTAL MFG., Co.. The 510(k) number is K172683.

When did Yamahachi Pink CAD/CAM Disk receive FDA 510(k) clearance?

Yamahachi Pink CAD/CAM Disk received FDA 510(k) clearance on 2018-01-16, under 510(k) number K172683.

Who is the listed applicant for Yamahachi Pink CAD/CAM Disk?

The FDA 510(k) record lists YAMAHACHI DENTAL MFG., Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yamahachi Pink CAD/CAM Disk?

The FDA product code for Yamahachi Pink CAD/CAM Disk is EBI.

其他以 YAMAHACHI DENTAL MFG., Co. 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。

K254091亮麗塗層（15ML）K233859BASIS FLOW II

相關器械（代碼：EBI）

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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