FDA 510(k)

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)

Número K: K200555 · 2021-05-13

Data da decisão2021-05-13

Código do produtoEMA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) 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 2021-05-13 under 510(k) number K200555. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) is a medical device that received FDA 510(k) clearance on 2021-05-13. The listed applicant is Prevest Denpro Limited. The 510(k) number is K200555.

When did Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) receive FDA 510(k) clearance?

Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) received FDA 510(k) clearance on 2021-05-13, under 510(k) number K200555.

Who is the listed applicant for Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

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 Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner)?

The FDA product code for Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) is EMA.

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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)K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)

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Fonte oficial

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