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FDA 510(k)

Aquasil Ultra + 智能濕印材料

K 號：K152861 · 2016-03-04

申請人Dentply International, Inc.
決定日期2016-03-04
產品代碼ELW
諮詢委員會DE
決定相當於

器材摘要

Aquasil Ultra + Smart Wetting Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Dentply International, Inc.. It received FDA 510(k) clearance on 2016-03-04 under 510(k) number K152861. 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 Aquasil Ultra + Smart Wetting Impression Material?

Aquasil Ultra + Smart Wetting Impression Material is a medical device that received FDA 510(k) clearance on 2016-03-04. The listed applicant is Dentply International, Inc.. The 510(k) number is K152861.

When did Aquasil Ultra + Smart Wetting Impression Material receive FDA 510(k) clearance?

Aquasil Ultra + Smart Wetting Impression Material received FDA 510(k) clearance on 2016-03-04, under 510(k) number K152861.

Who is the listed applicant for Aquasil Ultra + Smart Wetting Impression Material?

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

What is the FDA product code for Aquasil Ultra + Smart Wetting Impression Material?

The FDA product code for Aquasil Ultra + Smart Wetting Impression Material is ELW.

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：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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