FDA 510(k)

超溫Rez II

K 號：K211237 · 2021-07-13

決定日期2021-07-13

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

UltraTemp Rez II is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2021-07-13 under 510(k) number K211237. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UltraTemp Rez II?

UltraTemp Rez II is a medical device that received FDA 510(k) clearance on 2021-07-13. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K211237.

When did UltraTemp Rez II receive FDA 510(k) clearance?

UltraTemp Rez II received FDA 510(k) clearance on 2021-07-13, under 510(k) number K211237.

Who is the listed applicant for UltraTemp Rez II?

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

What is the FDA product code for UltraTemp Rez II?

The FDA product code for UltraTemp Rez II is EMA.

其他以 Ultradent Products, Inc. 為申請人之記錄

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相關器械（代碼：EMA）

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。

K262983EsTemp 偽裝體Spident Co., Ltd.K254201任何-瓷Mediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM 大眾化GC America, Inc.K253337REGEN 生物活性水泥Inter-Med, Inc.

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