FDA 510(k)

DX. Bond V Dental Bonding Adhesive

Número K: K232978 · 2023-09-22

Data da decisão2023-09-22

Código do produtoKLE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DX. Bond V Dental Bonding Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Sino-Dentex Co., Ltd.. It received FDA 510(k) clearance on 2023-09-22 under 510(k) number K232978. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DX. Bond V Dental Bonding Adhesive?

DX. Bond V Dental Bonding Adhesive is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Sino-Dentex Co., Ltd.. The 510(k) number is K232978.

When did DX. Bond V Dental Bonding Adhesive receive FDA 510(k) clearance?

DX. Bond V Dental Bonding Adhesive received FDA 510(k) clearance on 2023-09-22, under 510(k) number K232978.

Who is the listed applicant for DX. Bond V Dental Bonding Adhesive?

The FDA 510(k) record lists Sino-Dentex Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DX. Bond V Dental Bonding Adhesive?

The FDA product code for DX. Bond V Dental Bonding Adhesive is KLE.

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: KLE)

K262252MPa Max adhesiveDen-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products Company K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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.