FDA 510(k)

DENTIOIII系列（DENTIOIII，DENTIOIII-S）

K 號：K181297 · 2018-11-21

決定日期2018-11-21

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

DENTIOIII series (DENTIOIII, DENTIOIII-S) 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 2018-11-21 under 510(k) number K181297. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DENTIOIII series (DENTIOIII, DENTIOIII-S)?

DENTIOIII series (DENTIOIII, DENTIOIII-S) is a medical device that received FDA 510(k) clearance on 2018-11-21. The listed applicant is Hdx Will Corp.. The 510(k) number is K181297.

When did DENTIOIII series (DENTIOIII, DENTIOIII-S) receive FDA 510(k) clearance?

DENTIOIII series (DENTIOIII, DENTIOIII-S) received FDA 510(k) clearance on 2018-11-21, under 510(k) number K181297.

Who is the listed applicant for DENTIOIII series (DENTIOIII, DENTIOIII-S)?

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 DENTIOIII series (DENTIOIII, DENTIOIII-S)?

The FDA product code for DENTIOIII series (DENTIOIII, DENTIOIII-S) is MUH.

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 K212254DENTRI系列（DENTRIa、DENTRI-Ca、DENTRI-Sa）K192700Xcam K190357星-X，口腔X光系統 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：MUH）

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。

K251793SOTA雲端智慧感測器（1.5）Sota Cloud Corp.K252570EzSensor HD，EzSensor UHDQpix Solutions, Inc.K250687Cocoon獨立 (DX-7020s)Dexcowin Global, Inc.K251206數位X光牙科DentiMax Pro影像系統Dentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph)；VistaPano S 2.0 (VistaPano S)；ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph)；ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X感測器（型號：IOS-A15IF，HDI-15DGF）Qpix Solutions, Inc.

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。