FDA 510(k)

EthanZir Zirconia

K-번호: K191304 · 2019-11-04

결정일2019-11-04

제품 코드EIH

자문 위원회DE

결정Substantially Equivalent

기기 요약

EthanZir Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is Besorah Dental Solutions NZ Limited. It received FDA 510(k) clearance on 2019-11-04 under 510(k) number K191304. 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 EthanZir Zirconia?

EthanZir Zirconia is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Besorah Dental Solutions NZ Limited. The 510(k) number is K191304.

When did EthanZir Zirconia receive FDA 510(k) clearance?

EthanZir Zirconia received FDA 510(k) clearance on 2019-11-04, under 510(k) number K191304.

Who is the listed applicant for EthanZir Zirconia?

The FDA 510(k) record lists Besorah Dental Solutions NZ Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EthanZir Zirconia?

The FDA product code for EthanZir Zirconia is EIH.

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EthanZir Zirconia

기기 요약

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관련 임상시험

관련 기기 (코드: EIH)

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