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FDA 510(k)

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure

K-Number: K161987 · 2017-02-21

ApplicantDio Corporation
Decision Date2017-02-21
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is a medical device manufactured by Dio Corporation. It received FDA 510(k) clearance on 2017-02-21 under approval number K161987. 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) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Dio Corporation. The 510(k) number is K161987.

When was UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure approved by the FDA?

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure received FDA 510(k) clearance on 2017-02-21, under approval number K161987.

What company makes UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is manufactured by Dio Corporation.

What is the FDA product code for UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

The FDA product code for UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure is DZE.

Related Clinical Trials

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Related PubMed Literature

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)

Other Devices by Dio Corporation

K181037DIO CAD/CAM Abutment K182194UV Active Implant System K173975UF(II) Wide Fixture K170608UF(II) Implant System 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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