FDA 510(k)

JS Dental Lab Mouth Guard

Номер K: K210011 · 2021-07-16

ЗаявительAmpower Dental Laboratories, LLC

Дата решения2021-07-16

Код продуктаMQC

РешениеSubstantially Equivalent

Описание устройства

JS Dental Lab Mouth Guard is the device name listed in this FDA 510(k) record. The listed applicant is Ampower Dental Laboratories, LLC. It received FDA 510(k) clearance on 2021-07-16 under 510(k) number K210011. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the JS Dental Lab Mouth Guard?

JS Dental Lab Mouth Guard is a medical device that received FDA 510(k) clearance on 2021-07-16. The listed applicant is Ampower Dental Laboratories, LLC. The 510(k) number is K210011.

When did JS Dental Lab Mouth Guard receive FDA 510(k) clearance?

JS Dental Lab Mouth Guard received FDA 510(k) clearance on 2021-07-16, under 510(k) number K210011.

Who is the listed applicant for JS Dental Lab Mouth Guard?

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

What is the FDA product code for JS Dental Lab Mouth Guard?

The FDA product code for JS Dental Lab Mouth Guard is MQC.

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: MQC)

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemvia K251252NOBILCAM IMPAK DiscShandong Huge Dental Material Corporation K241729Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation K243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

Официальный источник

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