FDA 510(k)

TIA Tip, Cariosity, Transillumination Accessory Tip

Номер K: K213482 · 2022-04-29

Дата решения2022-04-29

Код продуктаNTK

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

TIA Tip, Cariosity, Transillumination Accessory Tip is the device name listed in this FDA 510(k) record. The listed applicant is D4D Technologies, LLC. It received FDA 510(k) clearance on 2022-04-29 under 510(k) number K213482. The device is classified under product code NTK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the TIA Tip, Cariosity, Transillumination Accessory Tip?

TIA Tip, Cariosity, Transillumination Accessory Tip is a medical device that received FDA 510(k) clearance on 2022-04-29. The listed applicant is D4D Technologies, LLC. The 510(k) number is K213482.

When did TIA Tip, Cariosity, Transillumination Accessory Tip receive FDA 510(k) clearance?

TIA Tip, Cariosity, Transillumination Accessory Tip received FDA 510(k) clearance on 2022-04-29, under 510(k) number K213482.

Who is the listed applicant for TIA Tip, Cariosity, Transillumination Accessory Tip?

The FDA 510(k) record lists D4D Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIA Tip, Cariosity, Transillumination Accessory Tip?

The FDA product code for TIA Tip, Cariosity, Transillumination Accessory Tip is NTK.

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: NTK)

K261847iTero Lumina™ ProAlign Technology , Ltd.K250771Primescan 2Dentsply Sirona, Inc.K240573iTero Lumina™ ProAlign Technology , Ltd.K193659iTero Element 5DAlign Technology, Inc.K182712DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH K172007CamX Triton HD Proxi HeadDuerr Dental AG

Официальный источник

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