FDA 510(k)

Bioceramic Root Repair Material (C-Root BP)

Número K: K240365 · 2024-05-10

RequerenteBeijing C-Root Dental Medical Devices Co., Ltd.

Data da decisão2024-05-10

Código do produtoKIF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bioceramic Root Repair Material (C-Root BP) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing C-Root Dental Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K240365. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Bioceramic Root Repair Material (C-Root BP)?

Bioceramic Root Repair Material (C-Root BP) is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Beijing C-Root Dental Medical Devices Co., Ltd.. The 510(k) number is K240365.

When did Bioceramic Root Repair Material (C-Root BP) receive FDA 510(k) clearance?

Bioceramic Root Repair Material (C-Root BP) received FDA 510(k) clearance on 2024-05-10, under 510(k) number K240365.

Who is the listed applicant for Bioceramic Root Repair Material (C-Root BP)?

The FDA 510(k) record lists Beijing C-Root Dental Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bioceramic Root Repair Material (C-Root BP)?

The FDA product code for Bioceramic Root Repair Material (C-Root BP) is KIF.

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Fonte oficial

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