Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

PMA de la FDA

Caries detection product with drug or biologic

Número de PMA: P170029 · 2025-03-03

SolicitanteCalcivis Limited
Fecha de decisión2025-03-03
Número PMAP170029
Código de productoQJX
Clase del dispositivoClase 3
Especialidad médicaU
Comité asesorDE

Resumen del 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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑