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FDA 510(k)

牙醫混合VPS印模材

K 號：K223892 · 2023-04-27

申請人Innovative Product Brands, Inc.
決定日期2023-04-27
產品代碼ELW
諮詢委員會DE
決定相當於

器材摘要

DentMix VPS Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Product Brands, Inc.. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K223892. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DentMix VPS Impression Material?

DentMix VPS Impression Material is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Innovative Product Brands, Inc.. The 510(k) number is K223892.

When did DentMix VPS Impression Material receive FDA 510(k) clearance?

DentMix VPS Impression Material received FDA 510(k) clearance on 2023-04-27, under 510(k) number K223892.

Who is the listed applicant for DentMix VPS Impression Material?

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

What is the FDA product code for DentMix VPS Impression Material?

The FDA product code for DentMix VPS Impression Material is ELW.

相關臨床試驗

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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

其他以 Innovative Product Brands, Inc. 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。

K220612PrimeLOC 附著系統

相關器械（代碼：ELW）

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。

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官方來源

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