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FDA 510(k)

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology

K 號：K160825 · 2016-09-27

申請人Dentsply Sirona
決定日期2016-09-27
產品代碼EKX
諮詢委員會DE
決定Substantially Equivalent

器材摘要

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K160825. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology?

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is Dentsply Sirona. The 510(k) number is K160825.

When did MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology receive FDA 510(k) clearance?

MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology received FDA 510(k) clearance on 2016-09-27, under 510(k) number K160825.

Who is the listed applicant for MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology?

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 MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology?

The FDA product code for MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology is EKX.

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其他以 Dentsply Sirona 為申請人之記錄

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相關器械（代碼：EKX）

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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