FDA 510(k)

Zirdent 牙齿陶瓷空白板 & 预着色牙齿陶瓷空白板

K号: K212259 · 2021-11-12

决定日期2021-11-12

产品代码EIH

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决定实质等同

器械摘要

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Zirdent New Material Co., Ltd.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K212259. 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 Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Zirdent New Material Co., Ltd.. The 510(k) number is K212259.

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

Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2021-11-12, under 510(k) number K212259.

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

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

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

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

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Zirdent 牙齿陶瓷空白板 & 预着色牙齿陶瓷空白板

器械摘要

常见问题

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