FDA 510(k)

CompleClear Plastic Orthodontic Bracket and Wire Appliance

Номер K: K150830 · 2016-08-26

ЗаявительOracrew

Дата решения2016-08-26

Код продуктаDYW

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

CompleClear Plastic Orthodontic Bracket and Wire Appliance is the device name listed in this FDA 510(k) record. The listed applicant is Oracrew. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K150830. 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 CompleClear Plastic Orthodontic Bracket and Wire Appliance?

CompleClear Plastic Orthodontic Bracket and Wire Appliance is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Oracrew. The 510(k) number is K150830.

When did CompleClear Plastic Orthodontic Bracket and Wire Appliance receive FDA 510(k) clearance?

CompleClear Plastic Orthodontic Bracket and Wire Appliance received FDA 510(k) clearance on 2016-08-26, under 510(k) number K150830.

Who is the listed applicant for CompleClear Plastic Orthodontic Bracket and Wire Appliance?

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

What is the FDA product code for CompleClear Plastic Orthodontic Bracket and Wire Appliance?

The FDA product code for CompleClear Plastic Orthodontic Bracket and Wire Appliance 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 K201940Braces on Demand BracketBraces on Demand, Inc.K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky Bio K180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.K160720Carriere Motion Clear Class IIOrtho Organizers, Inc.

Официальный источник

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