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FDA 510(k)

Implantswiss Dental Implant System, Implantswiss Dental Abutment System

K-Number: K181266 · 2018-11-01

ApplicantNovodent SA
Decision Date2018-11-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Implantswiss Dental Implant System, Implantswiss Dental Abutment System is a medical device manufactured by Novodent SA. It received FDA 510(k) clearance on 2018-11-01 under approval number K181266. 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 Implantswiss Dental Implant System, Implantswiss Dental Abutment System?

Implantswiss Dental Implant System, Implantswiss Dental Abutment System is a medical device that received FDA 510(k) clearance on 2018-11-01. It is manufactured by Novodent SA. The 510(k) number is K181266.

When was Implantswiss Dental Implant System, Implantswiss Dental Abutment System approved by the FDA?

Implantswiss Dental Implant System, Implantswiss Dental Abutment System received FDA 510(k) clearance on 2018-11-01, under approval number K181266.

What company makes Implantswiss Dental Implant System, Implantswiss Dental Abutment System?

Implantswiss Dental Implant System, Implantswiss Dental Abutment System is manufactured by Novodent SA.

What is the FDA product code for Implantswiss Dental Implant System, Implantswiss Dental Abutment System?

The FDA product code for Implantswiss Dental Implant System, Implantswiss Dental Abutment 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 Novodent SA

K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment System

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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