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FDA 510(k)

Materiais 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)

Número K: K213244 · 2022-09-09

RequerentePrevest Denpro Limited
Data da decisão2022-09-09
Código do produtoELW
Comité consultivoDE
DecisãoSubstantially Equivalent

Resumo do dispositivo

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) 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 2022-09-09 under 510(k) number K213244. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)?

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Prevest Denpro Limited. The 510(k) number is K213244.

When did Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) receive FDA 510(k) clearance?

Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) received FDA 510(k) clearance on 2022-09-09, under 510(k) number K213244.

Who is the listed applicant for Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)?

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 Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)?

The FDA product code for Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) is ELW.

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Dispositivos Relacionados (Código: ELW)

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Fonte oficial

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