FDA 510(k)

Neodent Implant System - Zirconia Implant System

K-Number: K201491 · 2020-12-22

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.

Decision Date2020-12-22

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Neodent Implant System - Zirconia Implant System is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2020-12-22 under approval number K201491. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neodent Implant System - Zirconia Implant System?

Neodent Implant System - Zirconia Implant System is a medical device that received FDA 510(k) clearance on 2020-12-22. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K201491.

When was Neodent Implant System - Zirconia Implant System approved by the FDA?

Neodent Implant System - Zirconia Implant System received FDA 510(k) clearance on 2020-12-22, under approval number K201491.

What company makes Neodent Implant System - Zirconia Implant System?

Neodent Implant System - Zirconia Implant System is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A..

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

The FDA product code for Neodent Implant System - Zirconia Implant System is DZE.

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Related PubMed Literature

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Related Devices (Code: DZE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.