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FDA 510(k)

Neodent Implant System - Zirconia Implant System

K-Number: K222026 · 2023-07-14

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.
Decision Date2023-07-14
Product CodeNHA
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 2023-07-14 under approval number K222026. The device is classified under product code NHA. 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 2023-07-14. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K222026.

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

Neodent Implant System - Zirconia Implant System received FDA 510(k) clearance on 2023-07-14, under approval number K222026.

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 NHA.

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by Jjgc Industria E Comercio DE Materiais Dentarios S.A.

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View all 28 devices →

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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.

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