FDA 510(k)

JUVORA Dental Disc, Ceramill PEEK by JUVORA

K-번호: K160918 · 2017-02-13

신청자Juvora

결정일2017-02-13

제품 코드EBI

자문 위원회DE

결정Substantially Equivalent

기기 요약

JUVORA Dental Disc, Ceramill PEEK by JUVORA is the device name listed in this FDA 510(k) record. The listed applicant is Juvora. It received FDA 510(k) clearance on 2017-02-13 under 510(k) number K160918. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the JUVORA Dental Disc, Ceramill PEEK by JUVORA?

JUVORA Dental Disc, Ceramill PEEK by JUVORA is a medical device that received FDA 510(k) clearance on 2017-02-13. The listed applicant is Juvora. The 510(k) number is K160918.

When did JUVORA Dental Disc, Ceramill PEEK by JUVORA receive FDA 510(k) clearance?

JUVORA Dental Disc, Ceramill PEEK by JUVORA received FDA 510(k) clearance on 2017-02-13, under 510(k) number K160918.

Who is the listed applicant for JUVORA Dental Disc, Ceramill PEEK by JUVORA?

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

What is the FDA product code for JUVORA Dental Disc, Ceramill PEEK by JUVORA?

The FDA product code for JUVORA Dental Disc, Ceramill PEEK by JUVORA is EBI.

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JUVORA Dental Disc, Ceramill PEEK by JUVORA

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: EBI)

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