FDA 510(k)

Ceramir Restore QuikCap

K-번호: K201937 · 2020-11-13

결정일2020-11-13

제품 코드EMA

자문 위원회DE

결정Substantially Equivalent

기기 요약

Ceramir Restore QuikCap is the device name listed in this FDA 510(k) record. The listed applicant is Doxa Dental AB. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K201937. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Ceramir Restore QuikCap?

Ceramir Restore QuikCap is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Doxa Dental AB. The 510(k) number is K201937.

When did Ceramir Restore QuikCap receive FDA 510(k) clearance?

Ceramir Restore QuikCap received FDA 510(k) clearance on 2020-11-13, under 510(k) number K201937.

Who is the listed applicant for Ceramir Restore QuikCap?

The FDA 510(k) record lists Doxa Dental AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceramir Restore QuikCap?

The FDA product code for Ceramir Restore QuikCap is EMA.

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Ceramir Restore QuikCap

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: EMA)

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