FDA 510(k)

CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid

Número K: K212563 · 2022-05-23

Data da decisão2022-05-23

Código do produtoKIF

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid 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 2022-05-23 under 510(k) number K212563. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid?

CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid is a medical device that received FDA 510(k) clearance on 2022-05-23. The listed applicant is Prevest Denpro Limited. The 510(k) number is K212563.

When did CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid receive FDA 510(k) clearance?

CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid received FDA 510(k) clearance on 2022-05-23, under 510(k) number K212563.

Who is the listed applicant for CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid?

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 CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid?

The FDA product code for CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid is KIF.

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Outros registros que listam Prevest Denpro Limited como candidato(a)

K233273C&B Ceramic; C&B Permanent; C&B Interim 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 K213244Materiais de Impressão Dental Accusil (Accusil Light Body Regular e Rápido, Accusil Heavy Body Regular e Rápido, Accusil Monofásico Regular e Rápido, Accusil Massa Regular e Rápido, Accusil Registo de Mordida)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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Fonte oficial

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