FDA 510(k)

JUVORA Dental Disc, Ceramill PEEK by JUVORA

Номер K: K160918 · 2017-02-13

ЗаявительJuvora

Дата решения2017-02-13

Код продуктаEBI

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: EBI)

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

Официальный источник

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