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FDA 510(k)

Neodent Implant System

K-Number: K153624 · 2016-04-15

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S
Decision Date2016-04-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Neodent Implant System is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S. It received FDA 510(k) clearance on 2016-04-15 under approval number K153624. 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?

Neodent Implant System is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S. The 510(k) number is K153624.

When was Neodent Implant System approved by the FDA?

Neodent Implant System received FDA 510(k) clearance on 2016-04-15, under approval number K153624.

What company makes Neodent Implant System?

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

What is the FDA product code for Neodent Implant System?

The FDA product code for Neodent Implant System is NHA.

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) 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) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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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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