FDA 510(k)

超温瑞兹II

K号: K211237 · 2021-07-13

决定日期2021-07-13

产品代码EMA

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决定实质等同

器械摘要

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.

常见问题

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.

列明Ultradent Products, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262228超越大体积填充流动复合树脂 K261404超易用 K240743峰值通用粘合剂 K240694FORMA 复合（色调 A3D）K221909J-Temp K220471VALO X，VALO X 配件镜片

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