FDA 510(k)

Ora-GUARD Dental Grind Guard

Номер K: K150492 · 2016-02-19

Дата решения2016-02-19

Код продуктаOBR

РешениеSubstantially Equivalent

Описание устройства

Ora-GUARD Dental Grind Guard is the device name listed in this FDA 510(k) record. The listed applicant is Bite Tech, Inc.. It received FDA 510(k) clearance on 2016-02-19 under 510(k) number K150492. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Ora-GUARD Dental Grind Guard?

Ora-GUARD Dental Grind Guard is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Bite Tech, Inc.. The 510(k) number is K150492.

When did Ora-GUARD Dental Grind Guard receive FDA 510(k) clearance?

Ora-GUARD Dental Grind Guard received FDA 510(k) clearance on 2016-02-19, under 510(k) number K150492.

Who is the listed applicant for Ora-GUARD Dental Grind Guard?

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

What is the FDA product code for Ora-GUARD Dental Grind Guard?

The FDA product code for Ora-GUARD Dental Grind Guard is OBR. This falls under the Orthopedic category.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: OBR)

K262559Mouth GuardChangSha ChuangDuoLe E-Commerce Co., Ltd.K260790G-Series Grind GuardASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media Limited K253641Owl Night GuardOwl Dental Lab, Inc.K252004enCore Night GuardEncore Guards K251778Remi Custom Night GuardRemi

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.