FDA 510(k)

DenQ Sub SLA Implant System

Número K: K240977 · 2024-09-13

RequerenteDenq

Data da decisão2024-09-13

Código do produtoDZE

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DenQ Sub SLA Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Denq. It received FDA 510(k) clearance on 2024-09-13 under 510(k) number K240977. 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 DenQ Sub SLA Implant System?

DenQ Sub SLA Implant System is a medical device that received FDA 510(k) clearance on 2024-09-13. The listed applicant is Denq. The 510(k) number is K240977.

When did DenQ Sub SLA Implant System receive FDA 510(k) clearance?

DenQ Sub SLA Implant System received FDA 510(k) clearance on 2024-09-13, under 510(k) number K240977.

Who is the listed applicant for DenQ Sub SLA Implant System?

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

What is the FDA product code for DenQ Sub SLA Implant System?

The FDA product code for DenQ Sub SLA Implant System is DZE.

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Fonte oficial

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