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FDA 510(k)

ALFA GATE Dental Implants System

K-Number: K182143 · 2019-10-03

ApplicantAlfa Gate Mazen, Ltd.
Decision Date2019-10-03
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ALFA GATE Dental Implants System is a medical device manufactured by Alfa Gate Mazen, Ltd.. It received FDA 510(k) clearance on 2019-10-03 under approval number K182143. 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 ALFA GATE Dental Implants System?

ALFA GATE Dental Implants System is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by Alfa Gate Mazen, Ltd.. The 510(k) number is K182143.

When was ALFA GATE Dental Implants System approved by the FDA?

ALFA GATE Dental Implants System received FDA 510(k) clearance on 2019-10-03, under approval number K182143.

What company makes ALFA GATE Dental Implants System?

ALFA GATE Dental Implants System is manufactured by Alfa Gate Mazen, Ltd..

What is the FDA product code for ALFA GATE Dental Implants System?

The FDA product code for ALFA GATE Dental Implants System is DZE.

Related Clinical Trials

NCT07608523 Marginal Bone Level Around Dental Implants in Periodontitis Patients COMPLETED NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_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)

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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