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FDA 510(k)

Conical Platform Dental Implants System

K-Number: K240202 · 2024-06-06

ApplicantNoris Medical , Ltd.
Decision Date2024-06-06
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Conical Platform Dental Implants System is a medical device manufactured by Noris Medical , Ltd.. It received FDA 510(k) clearance on 2024-06-06 under approval number K240202. 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 Conical Platform Dental Implants System?

Conical Platform Dental Implants System is a medical device that received FDA 510(k) clearance on 2024-06-06. It is manufactured by Noris Medical , Ltd.. The 510(k) number is K240202.

When was Conical Platform Dental Implants System approved by the FDA?

Conical Platform Dental Implants System received FDA 510(k) clearance on 2024-06-06, under approval number K240202.

What company makes Conical Platform Dental Implants System?

Conical Platform Dental Implants System is manufactured by Noris Medical , Ltd..

What is the FDA product code for Conical Platform Dental Implants System?

The FDA product code for Conical Platform Dental Implants System is DZE.

Related Clinical Trials

NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING NCT07608523 Marginal Bone Level Around Dental Implants in Periodontitis Patients COMPLETED NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07603609 Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain RECRUITING NCT07593807 TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis ACTIVE_NOT_RECRUITING NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (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 Noris Medical , Ltd.

K153043Noris Medical MBI Dental Implant System K151909Noris Medical Zygomatic Dental Implant System K162308Noris Medical MBI-2mm Dental Implant System K210852Noris Medical Dental Implants System - Cortical K210356Noris Medical Dental Implants System K241462LONGY Implant and LONGY-N Implant

View all 7 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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