FDA 510(k)

Neodent Implant System - Temporary Abutments

Número K: K191191 · 2019-12-05

RequerenteJjgc Industria E Comercio DE Materiais Dentarios S.A.

Data da decisão2019-12-05

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Neodent Implant System - Temporary Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2019-12-05 under 510(k) number K191191. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Neodent Implant System - Temporary Abutments?

Neodent Implant System - Temporary Abutments is a medical device that received FDA 510(k) clearance on 2019-12-05. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K191191.

When did Neodent Implant System - Temporary Abutments receive FDA 510(k) clearance?

Neodent Implant System - Temporary Abutments received FDA 510(k) clearance on 2019-12-05, under 510(k) number K191191.

Who is the listed applicant for Neodent Implant System - Temporary Abutments?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Implant System - Temporary Abutments?

The FDA product code for Neodent Implant System - Temporary Abutments is NHA.

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Fonte oficial

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