FDA 510(k)

AeroPro 離線預防系統

K 號：K180682 · 2019-02-27

決定日期2019-02-27

產品代碼EKX

諮詢委員會DE

決定相當於

器材摘要

AeroPro Cordless Prophy System is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Company Products. It received FDA 510(k) clearance on 2019-02-27 under 510(k) number K180682. 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 AeroPro Cordless Prophy System?

AeroPro Cordless Prophy System is a medical device that received FDA 510(k) clearance on 2019-02-27. The listed applicant is Premier Dental Company Products. The 510(k) number is K180682.

When did AeroPro Cordless Prophy System receive FDA 510(k) clearance?

AeroPro Cordless Prophy System received FDA 510(k) clearance on 2019-02-27, under 510(k) number K180682.

Who is the listed applicant for AeroPro Cordless Prophy System?

The FDA 510(k) record lists Premier Dental Company Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AeroPro Cordless Prophy System?

The FDA product code for AeroPro Cordless Prophy System is EKX.

其他以 Premier Dental Company Products 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。

K161580預先密封劑

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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