Noris Medical Zygomatic Dental Implant System
K-Number: K151909 · 2016-04-08
ApplicantNoris Medical , Ltd.
Decision Date2016-04-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Noris Medical Zygomatic Dental Implant System is a medical device manufactured by Noris Medical , Ltd.. It received FDA 510(k) clearance on 2016-04-08 under approval number K151909. 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 Noris Medical Zygomatic Dental Implant System?
Noris Medical Zygomatic Dental Implant System is a medical device that received FDA 510(k) clearance on 2016-04-08. It is manufactured by Noris Medical , Ltd.. The 510(k) number is K151909.
When was Noris Medical Zygomatic Dental Implant System approved by the FDA?
Noris Medical Zygomatic Dental Implant System received FDA 510(k) clearance on 2016-04-08, under approval number K151909.
What company makes Noris Medical Zygomatic Dental Implant System?
Noris Medical Zygomatic Dental Implant System is manufactured by Noris Medical , Ltd..
What is the FDA product code for Noris Medical Zygomatic Dental Implant System?
The FDA product code for Noris Medical Zygomatic Dental Implant System is DZE.
Related Clinical Trials
NCT01143558
Searching for Persistence of Infection in Lyme Disease
COMPLETED
NCT07137455
EDEN Intracardiac Electrogram Recording and Classifying System
ENROLLING_BY_INVITATION
NCT01174108
Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells
RECRUITING
NCT03280862
DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS
COMPLETED
NCT05701917
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
RECRUITING
NCT05391828
Persona MC vs PS RCT With ROSA
RECRUITING
Related PubMed Literature
PMID: 42181028
Systematic biocompatibility assessment of 4-µm surface silicone implants.
Biomaterials and biosystems (2026)
PMID: 42175114
Make Open Source Compliant: Validation in Non-Interventional Clinical Studies.
Studies in health technology and informatics (2026)
PMID: 42174947
Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks.
Studies in health technology and informatics (2026)
PMID: 42056377
Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh.
Scientific reports (2026)
Other Devices by Noris Medical , Ltd.
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.