FDA 510(k)

JUVORA珍珠白牙膠盤，JUVORA CERAMILL PEEK，珍珠白

K 號：K181331 · 2018-12-21

決定日期2018-12-21

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White is the device name listed in this FDA 510(k) record. The listed applicant is Juvora, Ltd.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) number K181331. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White?

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White is a medical device that received FDA 510(k) clearance on 2018-12-21. The listed applicant is Juvora, Ltd.. The 510(k) number is K181331.

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

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White received FDA 510(k) clearance on 2018-12-21, under 510(k) number K181331.

Who is the listed applicant for JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White?

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

What is the FDA product code for JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White?

The FDA product code for JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White is EBI.

相關器械（代碼：EBI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：EBI）

官方來源