FDA 510(k)

OSSIX PLUS

K 號：K160281 · 2016-08-04

決定日期2016-08-04

產品代碼NPL

諮詢委員會DE

決定相當於

器材摘要

OSSIX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Datum Dental, Ltd.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K160281. The device is classified under product code NPL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OSSIX PLUS?

OSSIX PLUS is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Datum Dental, Ltd.. The 510(k) number is K160281.

When did OSSIX PLUS receive FDA 510(k) clearance?

OSSIX PLUS received FDA 510(k) clearance on 2016-08-04, under 510(k) number K160281.

Who is the listed applicant for OSSIX PLUS?

The FDA 510(k) record lists Datum Dental, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSIX PLUS?

The FDA product code for OSSIX PLUS is NPL.

其他以 Datum Dental, 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。

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相關器械（代碼：NPL）

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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