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FDA 510(k)

DMi Dental Implant System

K-Number: K160060 · 2016-10-03

ApplicantDmi Innovative Medical Technology , Ltd.
Decision Date2016-10-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DMi Dental Implant System is a medical device manufactured by Dmi Innovative Medical Technology , Ltd.. It received FDA 510(k) clearance on 2016-10-03 under approval number K160060. 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 DMi Dental Implant System?

DMi Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-10-03. It is manufactured by Dmi Innovative Medical Technology , Ltd.. The 510(k) number is K160060.

When was DMi Dental Implant System approved by the FDA?

DMi Dental Implant System received FDA 510(k) clearance on 2016-10-03, under approval number K160060.

What company makes DMi Dental Implant System?

DMi Dental Implant System is manufactured by Dmi Innovative Medical Technology , Ltd..

What is the FDA product code for DMi Dental Implant System?

The FDA product code for DMi 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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