FDA 510(k)

Tatum Surgical Dental Implant System

Número K: K213576 · 2022-07-15

RequerenteSuncoast Dental, Inc. Dba Tatum Surgical

Data da decisão2022-07-15

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Tatum Surgical Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Suncoast Dental, Inc. Dba Tatum Surgical. It received FDA 510(k) clearance on 2022-07-15 under 510(k) number K213576. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tatum Surgical Dental Implant System?

Tatum Surgical Dental Implant System is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Suncoast Dental, Inc. Dba Tatum Surgical. The 510(k) number is K213576.

When did Tatum Surgical Dental Implant System receive FDA 510(k) clearance?

Tatum Surgical Dental Implant System received FDA 510(k) clearance on 2022-07-15, under 510(k) number K213576.

Who is the listed applicant for Tatum Surgical Dental Implant System?

The FDA 510(k) record lists Suncoast Dental, Inc. Dba Tatum Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tatum Surgical Dental Implant System?

The FDA product code for Tatum Surgical Dental Implant System is DZE.

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: DZE)

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC K260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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.