FDA 510(k)

JUVORA 牙科圆盘，Ceramill PEEK by JUVORA

K号: K160918 · 2017-02-13

申请人Juvora

决定日期2017-02-13

产品代码EBI

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决定实质等同

器械摘要

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.

常见问题

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.

官方来源

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JUVORA 牙科圆盘，Ceramill PEEK by JUVORA

器械摘要

常见问题

相关临床试验

相关器械（代码：EBI）

官方来源