FDA 510(k)

Panthera牙科磨製條

K 號：K192108 · 2020-04-08

決定日期2020-04-08

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

Panthera Dental Milled Bars is the device name listed in this FDA 510(k) record. The listed applicant is Panthera Dental, Inc.. It received FDA 510(k) clearance on 2020-04-08 under 510(k) number K192108. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Panthera Dental Milled Bars?

Panthera Dental Milled Bars is a medical device that received FDA 510(k) clearance on 2020-04-08. The listed applicant is Panthera Dental, Inc.. The 510(k) number is K192108.

When did Panthera Dental Milled Bars receive FDA 510(k) clearance?

Panthera Dental Milled Bars received FDA 510(k) clearance on 2020-04-08, under 510(k) number K192108.

Who is the listed applicant for Panthera Dental Milled Bars?

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

What is the FDA product code for Panthera Dental Milled Bars?

The FDA product code for Panthera Dental Milled Bars is NHA.

其他以 Panthera Dental, 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：NHA）

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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