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FDA 510(k)

MIS Internal Hex Dental Implant System

K-Number: K180282 · 2018-06-22

ApplicantMis Implants Technologies , Ltd.
Decision Date2018-06-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MIS Internal Hex Dental Implant System is a medical device manufactured by Mis Implants Technologies , Ltd.. It received FDA 510(k) clearance on 2018-06-22 under approval number K180282. 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 MIS Internal Hex Dental Implant System?

MIS Internal Hex Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-06-22. It is manufactured by Mis Implants Technologies , Ltd.. The 510(k) number is K180282.

When was MIS Internal Hex Dental Implant System approved by the FDA?

MIS Internal Hex Dental Implant System received FDA 510(k) clearance on 2018-06-22, under approval number K180282.

What company makes MIS Internal Hex Dental Implant System?

MIS Internal Hex Dental Implant System is manufactured by Mis Implants Technologies , Ltd..

What is the FDA product code for MIS Internal Hex Dental Implant System?

The FDA product code for MIS Internal Hex Dental 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)

Other Devices by Mis Implants Technologies , Ltd.

K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments K163349MIS V3 Conical Connection Dental Implant System­ K173326MIS CONNECT Conical Connection Abutment K182228MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

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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