FDA 510(k)

FORMA 复合（色调 A3D）

K号: K240694 · 2024-03-15

决定日期2024-03-15

产品代码EBF

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决定实质等同

器械摘要

FORMA Composite (Shade A3D) 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 2024-03-15 under 510(k) number K240694. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FORMA Composite (Shade A3D)?

FORMA Composite (Shade A3D) is a medical device that received FDA 510(k) clearance on 2024-03-15. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K240694.

When did FORMA Composite (Shade A3D) receive FDA 510(k) clearance?

FORMA Composite (Shade A3D) received FDA 510(k) clearance on 2024-03-15, under 510(k) number K240694.

Who is the listed applicant for FORMA Composite (Shade A3D)?

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 FORMA Composite (Shade A3D)?

The FDA product code for FORMA Composite (Shade A3D) is EBF.

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。

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