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FDA 510(k)

Microdent Ektos Implant System

K-Number: K153650 · 2016-05-20

ApplicantImplants Microdent System S.L
Decision Date2016-05-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Microdent Ektos Implant System is a medical device manufactured by Implants Microdent System S.L. It received FDA 510(k) clearance on 2016-05-20 under approval number K153650. 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 Microdent Ektos Implant System?

Microdent Ektos Implant System is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Implants Microdent System S.L. The 510(k) number is K153650.

When was Microdent Ektos Implant System approved by the FDA?

Microdent Ektos Implant System received FDA 510(k) clearance on 2016-05-20, under approval number K153650.

What company makes Microdent Ektos Implant System?

Microdent Ektos Implant System is manufactured by Implants Microdent System S.L.

What is the FDA product code for Microdent Ektos Implant System?

The FDA product code for Microdent Ektos Implant System is DZE.

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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)

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.

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