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FDA 510(k)

SD500 Elite LubeFree 高速手持工具，SD500 Elite 滑潤高速手持工具，SD500 Pro LubeFree 高速手持工具，Pro 滑潤高速手持工具

K 號：K192412 · 2020-01-06

申請人Dentalez, Inc.
決定日期2020-01-06
產品代碼EFB
諮詢委員會DE
決定相當於

器材摘要

SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez, Inc.. It received FDA 510(k) clearance on 2020-01-06 under 510(k) number K192412. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece?

SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Dentalez, Inc.. The 510(k) number is K192412.

When did SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece receive FDA 510(k) clearance?

SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece received FDA 510(k) clearance on 2020-01-06, under 510(k) number K192412.

Who is the listed applicant for SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece?

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

What is the FDA product code for SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece?

The FDA product code for SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece is EFB.

相關臨床試驗

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其他以 Dentalez, Inc. 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：EFB）

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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