FDA 510(k)

Nissin 牙科氧化锆空白 & 牙科氧化锆预着色空白

K号: K160367 · 2016-07-27

决定日期2016-07-27

产品代码EIH

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决定实质等同

器械摘要

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Nissin-Metec China Co., Ltd.. It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K160367. 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 Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Nissin-Metec China Co., Ltd.. The 510(k) number is K160367.

When did Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank receive FDA 510(k) clearance?

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2016-07-27, under 510(k) number K160367.

Who is the listed applicant for Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA 510(k) record lists Nissin-Metec China Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

The FDA product code for Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is EIH.

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Nissin 牙科氧化锆空白 & 牙科氧化锆预着色空白

器械摘要

常见问题

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