FDA 510(k)

DENTRIa 系列

K 號：K160140 · 2016-09-30

決定日期2016-09-30

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

DENTRIa series is the device name listed in this FDA 510(k) record. The listed applicant is Hdx Will Corp.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K160140. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DENTRIa series?

DENTRIa series is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Hdx Will Corp.. The 510(k) number is K160140.

When did DENTRIa series receive FDA 510(k) clearance?

DENTRIa series received FDA 510(k) clearance on 2016-09-30, under 510(k) number K160140.

Who is the listed applicant for DENTRIa series?

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

What is the FDA product code for DENTRIa series?

The FDA product code for DENTRIa series is OAS.

其他以 Hdx Will Corp. 為申請人之記錄

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K211159Eco-x 系列產品（eco-x, eco-x-s）K211114將此設備名稱醫療設備規範文本翻譯為繁體中文。保留公司/產品名稱、FDA、510(k)、PMA、NCT、PMID、識別符和網址。政策：medical-regulatory-v1。僅返回翻譯。 Will3D K212254DENTRI系列（DENTRIa、DENTRI-Ca、DENTRI-Sa）K192700Xcam K190357星-X，口腔X光系統 K181297DENTIOIII系列（DENTIOIII，DENTIOIII-S）

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相關器械（代碼：OAS）

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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