FDA 510(k)

Clearform Aligners

Номер K: K191838 · 2020-03-20

Дата решения2020-03-20

Код продуктаNXC

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Clearform Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Motor City Lab Works. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K191838. 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 Clearform Aligners?

Clearform Aligners is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Motor City Lab Works. The 510(k) number is K191838.

When did Clearform Aligners receive FDA 510(k) clearance?

Clearform Aligners received FDA 510(k) clearance on 2020-03-20, under 510(k) number K191838.

Who is the listed applicant for Clearform Aligners?

The FDA 510(k) record lists Motor City Lab Works as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clearform Aligners?

The FDA product code for Clearform 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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