FDA 510(k)

JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White

Номер K: K181331 · 2018-12-21

ЗаявительJuvora, Ltd.

Дата решения2018-12-21

Код продуктаEBI

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.