FDA 510(k)

Infinity / Infinity Cross Flex Dental Systems

Número K: K180935 · 2020-02-05

RequerenteOlsen Industria E Comercio S.A.

Data da decisão2020-02-05

Código do produtoEIA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infinity / Infinity Cross Flex Dental Systems is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Industria E Comercio S.A.. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K180935. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Infinity / Infinity Cross Flex Dental Systems?

Infinity / Infinity Cross Flex Dental Systems is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Olsen Industria E Comercio S.A.. The 510(k) number is K180935.

When did Infinity / Infinity Cross Flex Dental Systems receive FDA 510(k) clearance?

Infinity / Infinity Cross Flex Dental Systems received FDA 510(k) clearance on 2020-02-05, under 510(k) number K180935.

Who is the listed applicant for Infinity / Infinity Cross Flex Dental Systems?

The FDA 510(k) record lists Olsen Industria E Comercio S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infinity / Infinity Cross Flex Dental Systems?

The FDA product code for Infinity / Infinity Cross Flex Dental Systems is EIA.

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: EIA)

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark Corporation K251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair Business K243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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.