FDA 510(k)

C&B Ceramic; C&B Permanent; C&B Interim

N.º K: K233273 · 2024-11-27

Fecha de decisión2024-11-27

Código de productoEBF

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

C&B Ceramic; C&B Permanent; C&B Interim is the device name listed in this FDA 510(k) record. The listed applicant is Prevest Denpro Limited. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K233273. 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 C&B Ceramic; C&B Permanent; C&B Interim?

C&B Ceramic; C&B Permanent; C&B Interim is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Prevest Denpro Limited. The 510(k) number is K233273.

When did C&B Ceramic; C&B Permanent; C&B Interim receive FDA 510(k) clearance?

C&B Ceramic; C&B Permanent; C&B Interim received FDA 510(k) clearance on 2024-11-27, under 510(k) number K233273.

Who is the listed applicant for C&B Ceramic; C&B Permanent; C&B Interim?

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

What is the FDA product code for C&B Ceramic; C&B Permanent; C&B Interim?

The FDA product code for C&B Ceramic; C&B Permanent; C&B Interim is EBF.

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Otros registros que enlistan a Prevest Denpro Limited como solicitante

K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT K231696Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal K213244Materiales de Impresión Dental Accusil (Accusil Light Body Regular y Rápido, Accusil Heavy Body Regular y Rápido, Accusil Monofásico Regular y Rápido, Accusil Putty Regular y Rápido, Accusil Registro de Mordida)K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)K200555Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

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Fuente oficial

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