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.

FDA 510(k)

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)

N.º K: K172761 · 2017-11-17

SolicitanteShanghai New Century Dental Materials Co., Ltd.
Fecha de decisión2017-11-17
Código de productoEIH
Comité asesorDE
DecisiónSubstantially Equivalent

Resumen del dispositivo

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai New Century Dental Materials Co., Ltd.. It received FDA 510(k) clearance on 2017-11-17 under 510(k) number K172761. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Shanghai New Century Dental Materials Co., Ltd.. The 510(k) number is K172761.

When did New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) receive FDA 510(k) clearance?

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) received FDA 510(k) clearance on 2017-11-17, under 510(k) number K172761.

Who is the listed applicant for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

The FDA 510(k) record lists Shanghai New Century Dental Materials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)?

The FDA product code for New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) is EIH.

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

Dispositivos relacionados (Código: EIH)

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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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.

↑