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FDA 510(k)

NR Line Implant System

K-Number: K153268 · 2016-07-20

ApplicantDentium Co., Ltd.
Decision Date2016-07-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NR Line Implant System is a medical device manufactured by Dentium Co., Ltd.. It received FDA 510(k) clearance on 2016-07-20 under approval number K153268. 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 NR Line Implant System?

NR Line Implant System is a medical device that received FDA 510(k) clearance on 2016-07-20. It is manufactured by Dentium Co., Ltd.. The 510(k) number is K153268.

When was NR Line Implant System approved by the FDA?

NR Line Implant System received FDA 510(k) clearance on 2016-07-20, under approval number K153268.

What company makes NR Line Implant System?

NR Line Implant System is manufactured by Dentium Co., Ltd..

What is the FDA product code for NR Line Implant System?

The FDA product code for NR Line 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 Dentium Co., Ltd.

K161713Dentium CAD/CAM Abutments K160828Dentium Implantium & SuperLine Prosthetics K160483Burn-out Cylinder and Angled Screw Abutments K171126Implantium II K170384Dentium NR Line CAD/CAM Abutments K160965SuperLine

View all 13 devices →

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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