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FDA PMA

Caries detection product with drug or biologic

Número do PMA: P170029 · 2025-03-03

RequerenteCalcivis Limited
Data da decisão2025-03-03
Número PMAP170029
Código do produtoQJX
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoDE

Resumo do dispositivo

Caries detection product with drug or biologic is the device name listed in this FDA 510(k) record. The listed applicant is Calcivis Limited. It received FDA 510(k) clearance on 2025-03-03. The device is classified under product code QJX. It was reviewed by the DE advisory panel.

Perguntas frequentes

What is the Caries detection product with drug or biologic?

Caries detection product with drug or biologic is a medical device that received FDA 510(k) clearance on 2025-03-03. The listed applicant is Calcivis Limited.

When did Caries detection product with drug or biologic receive FDA 510(k) clearance?

The clearance date for Caries detection product with drug or biologic can be found in the official FDA records.

Who is the listed applicant for Caries detection product with drug or biologic?

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

What is the FDA product code for Caries detection product with drug or biologic?

The FDA product code for Caries detection product with drug or biologic is QJX.

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Fonte oficial

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