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FDA 510(k)

Bonafix TWO - Dental Implant System

K-Number: K162853 · 2017-07-14

ApplicantBonafix Surgical and Dental Implants
Decision Date2017-07-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bonafix TWO - Dental Implant System is a medical device manufactured by Bonafix Surgical and Dental Implants. It received FDA 510(k) clearance on 2017-07-14 under approval number K162853. 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 Bonafix TWO - Dental Implant System?

Bonafix TWO - Dental Implant System is a medical device that received FDA 510(k) clearance on 2017-07-14. It is manufactured by Bonafix Surgical and Dental Implants. The 510(k) number is K162853.

When was Bonafix TWO - Dental Implant System approved by the FDA?

Bonafix TWO - Dental Implant System received FDA 510(k) clearance on 2017-07-14, under approval number K162853.

What company makes Bonafix TWO - Dental Implant System?

Bonafix TWO - Dental Implant System is manufactured by Bonafix Surgical and Dental Implants.

What is the FDA product code for Bonafix TWO - Dental Implant System?

The FDA product code for Bonafix TWO - Dental 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)

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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