FDA 510(k)

Mouth Guard (ATG0603R)

Número K: K231865 · 2023-11-06

Data da decisão2023-11-06

Código do produtoOBR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Mouth Guard (ATG0603R) is the device name listed in this FDA 510(k) record. The listed applicant is Reazeal Corp. It received FDA 510(k) clearance on 2023-11-06 under 510(k) number K231865. 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.

Perguntas frequentes

What is the Mouth Guard (ATG0603R)?

Mouth Guard (ATG0603R) is a medical device that received FDA 510(k) clearance on 2023-11-06. The listed applicant is Reazeal Corp. The 510(k) number is K231865.

When did Mouth Guard (ATG0603R) receive FDA 510(k) clearance?

Mouth Guard (ATG0603R) received FDA 510(k) clearance on 2023-11-06, under 510(k) number K231865.

Who is the listed applicant for Mouth Guard (ATG0603R)?

The FDA 510(k) record lists Reazeal Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mouth Guard (ATG0603R)?

The FDA product code for Mouth Guard (ATG0603R) is OBR. This falls under the Orthopedic category.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Dispositivos Relacionados (Código: 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

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.