FDA 510(k)

CAPO BULK FILL

N.º K: K152471 · 2016-08-04

Fecha de decisión2016-08-04

Código de productoEBF

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

CAPO BULK FILL is the device name listed in this FDA 510(k) record. The listed applicant is Schuetz Dental GmbH. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K152471. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CAPO BULK FILL?

CAPO BULK FILL is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Schuetz Dental GmbH. The 510(k) number is K152471.

When did CAPO BULK FILL receive FDA 510(k) clearance?

CAPO BULK FILL received FDA 510(k) clearance on 2016-08-04, under 510(k) number K152471.

Who is the listed applicant for CAPO BULK FILL?

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

What is the FDA product code for CAPO BULK FILL?

The FDA product code for CAPO BULK FILL is EBF.

Dispositivos relacionados (Código: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

Fuente oficial

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