FDA 510(k)

Braces on Demand Bracket

Номер K: K201940 · 2020-12-03

Дата решения2020-12-03

Код продуктаDYW

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

Braces on Demand Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Braces on Demand, Inc.. It received FDA 510(k) clearance on 2020-12-03 under 510(k) number K201940. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Braces on Demand Bracket?

Braces on Demand Bracket is a medical device that received FDA 510(k) clearance on 2020-12-03. The listed applicant is Braces on Demand, Inc.. The 510(k) number is K201940.

When did Braces on Demand Bracket receive FDA 510(k) clearance?

Braces on Demand Bracket received FDA 510(k) clearance on 2020-12-03, under 510(k) number K201940.

Who is the listed applicant for Braces on Demand Bracket?

The FDA 510(k) record lists Braces on Demand, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Braces on Demand Bracket?

The FDA product code for Braces on Demand Bracket is DYW.

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: DYW)

K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.K251196Composite Orthodontic Brackets and ButtonsEc Certification Service GmbH K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky Bio K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.K160720Carriere Motion Clear Class IIOrtho Organizers, Inc.K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew

Официальный источник

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