FDA 510(k)

新世纪全陶瓷氧化锆牙冠块（未着色和预着色）

K号: K172761 · 2017-11-17

申请人Shanghai New Century Dental Materials Co., Ltd.

决定日期2017-11-17

产品代码EIH

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决定实质等同

器械摘要

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai New Century Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K172761. 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 New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Shanghai New Century Dental Materials Co., Ltd.. The 510(k) number is K172761.

When did New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) receive FDA 510(k) clearance?

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172761.

Who is the listed applicant for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

The FDA 510(k) record lists Shanghai New Century Dental Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

The FDA product code for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is EIH.

官方来源

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新世纪全陶瓷氧化锆牙冠块（未着色和预着色）

器械摘要

常见问题

相关临床试验

相关器械（代码：EIH）

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