FDA 510(k)

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

K-번호: K221242 · 2022-07-29

결정일2022-07-29

제품 코드EIH

자문 위원회DE

결정Substantially Equivalent

기기 요약

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vsmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-29 under 510(k) number K221242. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank?

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank is a medical device that received FDA 510(k) clearance on 2022-07-29. The listed applicant is Hunan Vsmile Biotechnology Co., Ltd.. The 510(k) number is K221242.

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

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank received FDA 510(k) clearance on 2022-07-29, under 510(k) number K221242.

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

The FDA 510(k) record lists Hunan Vsmile Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Hunan Vsmile Biotechnology Co., Ltd.를 신청인으로 등재한 기타 기록

K242407Dental Glass Ceramics Blocks (HT, LT, MT)

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