FDA 510(k)

Neodent Implant System - Helix Short Surgical Kit Cases

Número K: K223662 · 2023-04-20

RequerenteJjgc Industria E Comercio DE Materiais Dentarios S.A.

Data da decisão2023-04-20

Código do produtoKCT

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

Neodent Implant System - Helix Short Surgical Kit Cases 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 2023-04-20 under 510(k) number K223662. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Neodent Implant System - Helix Short Surgical Kit Cases?

Neodent Implant System - Helix Short Surgical Kit Cases is a medical device that received FDA 510(k) clearance on 2023-04-20. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K223662.

When did Neodent Implant System - Helix Short Surgical Kit Cases receive FDA 510(k) clearance?

Neodent Implant System - Helix Short Surgical Kit Cases received FDA 510(k) clearance on 2023-04-20, under 510(k) number K223662.

Who is the listed applicant for Neodent Implant System - Helix Short Surgical Kit Cases?

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 - Helix Short Surgical Kit Cases?

The FDA product code for Neodent Implant System - Helix Short Surgical Kit Cases is KCT.

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Outros registros que listam Jjgc Industria E Comercio DE Materiais Dentarios S.A. como candidato(a)

K222026Neodent Implant System - Zirconia Implant System K223638Neodent Implant System - Helix Short Implant System K220251Neodent Implant System - GM Narrow Implant System K210336Neodent Implant System - Zirconia Implant System K203542Neodent Implant System - Mini Abutment 60°K203382Neodent Implant System-Easy Pack

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Fonte oficial

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