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FDA 510(k)

法蘭茲矽酸鋁牙冠

K 號：K203072 · 2022-01-19

申請人Franz Biotech, Inc.
決定日期2022-01-19
產品代碼ELL
諮詢委員會DE
決定相當於

器材摘要

Franz Zirconia Dental Crown is the device name listed in this FDA 510(k) record. The listed applicant is Franz Biotech, Inc.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K203072. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Franz Zirconia Dental Crown?

Franz Zirconia Dental Crown is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Franz Biotech, Inc.. The 510(k) number is K203072.

When did Franz Zirconia Dental Crown receive FDA 510(k) clearance?

Franz Zirconia Dental Crown received FDA 510(k) clearance on 2022-01-19, under 510(k) number K203072.

Who is the listed applicant for Franz Zirconia Dental Crown?

The FDA 510(k) record lists Franz Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Franz Zirconia Dental Crown?

The FDA product code for Franz Zirconia Dental Crown is ELL.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：ELL）

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。

K240586附加製造氧化鋯定制修復體Hangzhou Thales Medtech Co., Ltd.K162043諾貝爾普雷塞拉 HT ML FCZ 橋接器Nobel Biocare ABK153534諾貝爾普雷塞拉 HT ML 全形氧化鋯牙冠Nobel Biocare AB

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