FDA 510(k)

Perfit ZR ST 牙齿氧化锆空白, Perfit ZR UT 牙齿氧化锆空白

K号: K203499 · 2021-04-05

决定日期2021-04-05

产品代码EIH

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决定实质等同

器械摘要

Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank is the device name listed in this FDA 510(k) record. The listed applicant is Vatech Acucera, Inc.. It received FDA 510(k) clearance on 2021-04-05 under 510(k) number K203499. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank?

Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank is a medical device that received FDA 510(k) clearance on 2021-04-05. The listed applicant is Vatech Acucera, Inc.. The 510(k) number is K203499.

When did Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank receive FDA 510(k) clearance?

Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank received FDA 510(k) clearance on 2021-04-05, under 510(k) number K203499.

Who is the listed applicant for Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank?

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

What is the FDA product code for Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank?

The FDA product code for Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank is EIH.

列明Vatech Acucera, 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。

K222686Perfit FS 牙齿氧化锆全烧结块 K203590Perfit FS 牙齿氧化锆全烧结块 K203351Perfit ZR HT 牙齿氧化锆空白

官方来源

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