FDA 510(k)

支撐CAD

K 號：K193352 · 2021-07-21

決定日期2021-07-21

產品代碼PNP

諮詢委員會DE

決定相當於

器材摘要

AbutmentCAD is the device name listed in this FDA 510(k) record. The listed applicant is Exocad GmbH. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K193352. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AbutmentCAD?

AbutmentCAD is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Exocad GmbH. The 510(k) number is K193352.

When did AbutmentCAD receive FDA 510(k) clearance?

AbutmentCAD received FDA 510(k) clearance on 2021-07-21, under 510(k) number K193352.

Who is the listed applicant for AbutmentCAD?

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

What is the FDA product code for AbutmentCAD?

The FDA product code for AbutmentCAD is PNP.

其他以 Exocad GmbH 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。

K213302外星行星 K183458外星2.3

相關器械（代碼：PNP）

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。

K233252斯特羅曼CARES視覺與諾瓦牙醫CADInstitut Straumann AG K231529雲點快速設計臥椅Prismatik Dentalcraft, Inc.K221107TRUSTRgorithm Korea K200100支撐設計3Shape A/S K200191西隆納牙科CAD/CAM系統搭配InLab軟體Dentsply Sirona K181932DTX Studio設計Nobel Biocare AB

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。