FDA 510(k)

斯特羅曼CARES視覺與諾瓦牙醫CAD

K 號：K233252 · 2024-12-26

決定日期2024-12-26

產品代碼PNP

諮詢委員會DE

決定相當於

器材摘要

Straumann CARES Visual and Nova Dental CAD is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2024-12-26 under 510(k) number K233252. 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 Straumann CARES Visual and Nova Dental CAD?

Straumann CARES Visual and Nova Dental CAD is a medical device that received FDA 510(k) clearance on 2024-12-26. The listed applicant is Institut Straumann AG. The 510(k) number is K233252.

When did Straumann CARES Visual and Nova Dental CAD receive FDA 510(k) clearance?

Straumann CARES Visual and Nova Dental CAD received FDA 510(k) clearance on 2024-12-26, under 510(k) number K233252.

Who is the listed applicant for Straumann CARES Visual and Nova Dental CAD?

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

What is the FDA product code for Straumann CARES Visual and Nova Dental CAD?

The FDA product code for Straumann CARES Visual and Nova Dental CAD is PNP.

其他以 Institut Straumann AG 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。

K260726斯特羅曼® ProClean™ 裝籠 (041.800 ; 041.801)K260460Neodent金色調定制牙根，Medentika定制牙根金色調 K252168斯特羅曼® BLC植入物 - 指示範圍擴大 K253315Straumann Variobase Abutments XC用於橋梁/條 K250294斯特羅曼® RidgeFit植入物 K243278自訂基座

查看所有 57 項裝置 →

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。

K231529雲點快速設計臥椅Prismatik Dentalcraft, Inc.K221107TRUSTRgorithm Korea K193352支撐CADExocad GmbH 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。