FDA 510(k)

SIMPLANT Online Case Review and SIMPLANT Editor

K 號：K161118 · 2016-07-28

決定日期2016-07-28

產品代碼LLZ

諮詢委員會RA

決定Substantially Equivalent

器材摘要

SIMPLANT Online Case Review and SIMPLANT Editor is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161118. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SIMPLANT Online Case Review and SIMPLANT Editor?

SIMPLANT Online Case Review and SIMPLANT Editor is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Dentsply Sirona. The 510(k) number is K161118.

When did SIMPLANT Online Case Review and SIMPLANT Editor receive FDA 510(k) clearance?

SIMPLANT Online Case Review and SIMPLANT Editor received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161118.

Who is the listed applicant for SIMPLANT Online Case Review and SIMPLANT Editor?

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

What is the FDA product code for SIMPLANT Online Case Review and SIMPLANT Editor?

The FDA product code for SIMPLANT Online Case Review and SIMPLANT Editor is LLZ.

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相關器械（代碼：LLZ）

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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