FDA 510(k)

支撐設計

K 號：K200100 · 2020-10-07

決定日期2020-10-07

產品代碼PNP

諮詢委員會DE

決定相當於

器材摘要

Abutment Design is the device name listed in this FDA 510(k) record. The listed applicant is 3Shape A/S. It received FDA 510(k) clearance on 2020-10-07 under 510(k) number K200100. 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 Abutment Design?

Abutment Design is a medical device that received FDA 510(k) clearance on 2020-10-07. The listed applicant is 3Shape A/S. The 510(k) number is K200100.

When did Abutment Design receive FDA 510(k) clearance?

Abutment Design received FDA 510(k) clearance on 2020-10-07, under 510(k) number K200100.

Who is the listed applicant for Abutment Design?

The FDA 510(k) record lists 3Shape A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Abutment Design?

The FDA product code for Abutment Design is PNP.

其他以 3Shape A/S 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。

K1919113Shape Splint Design K180941正骨科系統 K171634正骨科系統 K163677正骨科系統 K161884正骨科系統 K1514553Shape Abutment Designer Software

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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 K193352支撐CADExocad GmbH 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

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