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FDA 510(k)

Implacil Implant System

K-Number: K202832 · 2021-05-26

ApplicantImplacil DE Bortoli Material Odontologico Ltda
Decision Date2021-05-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Implacil Implant System is a medical device manufactured by Implacil DE Bortoli Material Odontologico Ltda. It received FDA 510(k) clearance on 2021-05-26 under approval number K202832. 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 Implacil Implant System?

Implacil Implant System is a medical device that received FDA 510(k) clearance on 2021-05-26. It is manufactured by Implacil DE Bortoli Material Odontologico Ltda. The 510(k) number is K202832.

When was Implacil Implant System approved by the FDA?

Implacil Implant System received FDA 510(k) clearance on 2021-05-26, under approval number K202832.

What company makes Implacil Implant System?

Implacil Implant System is manufactured by Implacil DE Bortoli Material Odontologico Ltda.

What is the FDA product code for Implacil Implant System?

The FDA product code for Implacil Implant System is DZE.

Related Clinical Trials

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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)

Other Devices by Implacil DE Bortoli Material Odontologico Ltda

K183024Implacil Implant System

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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