FDA 510(k)

Clear Image Aligners

Номер K: K183643 · 2019-01-03

ЗаявительSpecialty Appliance Works, Inc.

Дата решения2019-01-03

Код продуктаNXC

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Clear Image Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Appliance Works, Inc.. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K183643. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Clear Image Aligners?

Clear Image Aligners is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Specialty Appliance Works, Inc.. The 510(k) number is K183643.

When did Clear Image Aligners receive FDA 510(k) clearance?

Clear Image Aligners received FDA 510(k) clearance on 2019-01-03, under 510(k) number K183643.

Who is the listed applicant for Clear Image Aligners?

The FDA 510(k) record lists Specialty Appliance Works, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear Image Aligners?

The FDA product code for Clear Image Aligners is NXC.

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: NXC)

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

Официальный источник

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