FDA 510(k)

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece

Номер K: K222845 · 2023-11-28

Дата решения2023-11-28

Код продуктаMQC

РешениеSubstantially Equivalent

Описание устройства

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece is the device name listed in this FDA 510(k) record. The listed applicant is Frey Oral Technologies, LLC. It received FDA 510(k) clearance on 2023-11-28 under 510(k) number K222845. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece?

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Frey Oral Technologies, LLC. The 510(k) number is K222845.

When did Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece receive FDA 510(k) clearance?

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece received FDA 510(k) clearance on 2023-11-28, under 510(k) number K222845.

Who is the listed applicant for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece?

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

What is the FDA product code for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece?

The FDA product code for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece 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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