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FDA 510(k)

GMI Frontier Dental Implant System

K-Number: K161593 · 2017-01-19

ApplicantIlerimplant S.L
Decision Date2017-01-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GMI Frontier Dental Implant System is a medical device manufactured by Ilerimplant S.L. It received FDA 510(k) clearance on 2017-01-19 under approval number K161593. 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 GMI Frontier Dental Implant System?

GMI Frontier Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Ilerimplant S.L. The 510(k) number is K161593.

When was GMI Frontier Dental Implant System approved by the FDA?

GMI Frontier Dental Implant System received FDA 510(k) clearance on 2017-01-19, under approval number K161593.

What company makes GMI Frontier Dental Implant System?

GMI Frontier Dental Implant System is manufactured by Ilerimplant S.L.

What is the FDA product code for GMI Frontier Dental Implant System?

The FDA product code for GMI Frontier Dental Implant System is DZE.

Related Clinical Trials

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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)

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

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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