FDA 510(k)

DENTRI系列（DENTRIa、DENTRI-Ca、DENTRI-Sa）

K 號：K212254 · 2021-10-19

決定日期2021-10-19

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) 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 2021-10-19 under 510(k) number K212254. 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, DENTRI-Ca, DENTRI-Sa)?

DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) is a medical device that received FDA 510(k) clearance on 2021-10-19. The listed applicant is Hdx Will Corp.. The 510(k) number is K212254.

When did DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) receive FDA 510(k) clearance?

DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) received FDA 510(k) clearance on 2021-10-19, under 510(k) number K212254.

Who is the listed applicant for DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)?

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 (DENTRIa, DENTRI-Ca, DENTRI-Sa)?

The FDA product code for DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) is OAS.

其他以 Hdx Will Corp. 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。

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 K192700Xcam K190357星-X，口腔X光系統 K181297DENTIOIII系列（DENTIOIII，DENTIOIII-S）K172168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。 WillCeph

查看所有 9 項裝置 →

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。

K261748牙科圓錐束計算機斷層掃描儀（mDX-15P系列）Hefei Meyer Optoelectronic Technology, Inc.K250839牙科X光系統Changzhou Boen Zhongding Medical Technology Co., Ltd.K260662牙科圓锥束計算機斷層掃描系統Yofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093綠色X 12 VE (PHT-70CHS)；綠色X VE (PHT-70CHS)VATECH Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。