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FDA 510(k)

UF(II) Implant System

K-Number: K170608 · 2018-03-30

ApplicantDio Corporation
Decision Date2018-03-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UF(II) Implant System is a medical device manufactured by Dio Corporation. It received FDA 510(k) clearance on 2018-03-30 under approval number K170608. 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 UF(II) Implant System?

UF(II) Implant System is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Dio Corporation. The 510(k) number is K170608.

When was UF(II) Implant System approved by the FDA?

UF(II) Implant System received FDA 510(k) clearance on 2018-03-30, under approval number K170608.

What company makes UF(II) Implant System?

UF(II) Implant System is manufactured by Dio Corporation.

What is the FDA product code for UF(II) Implant System?

The FDA product code for UF(II) 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)

Other Devices by Dio Corporation

K161987UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure K181037DIO CAD/CAM Abutment K182194UV Active Implant System K173975UF(II) Wide Fixture K190048UF(II) Anatomic abutment K193623DIOnavi-Denture

View all 11 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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