FDA 510(k)

DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)

Номер K: K172918 · 2017-12-18

Дата решения2017-12-18

Код продуктаMUH

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) is the device name listed in this FDA 510(k) record. The listed applicant is Kavo Dental Technologies, LLC. It received FDA 510(k) clearance on 2017-12-18 under 510(k) number K172918. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)?

DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) is a medical device that received FDA 510(k) clearance on 2017-12-18. The listed applicant is Kavo Dental Technologies, LLC. The 510(k) number is K172918.

When did DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) receive FDA 510(k) clearance?

DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) received FDA 510(k) clearance on 2017-12-18, under 510(k) number K172918.

Who is the listed applicant for DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)?

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

What is the FDA product code for DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)?

The FDA product code for DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) is MUH.

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: MUH)

K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687Cocoon Solo (DX-7020s)Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)VATECH Co., Ltd.K242778X Sensor (Model: IOS-A15IF, HDI-15DGF)Qpix Solutions, Inc.

Официальный источник

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