FDA 510(k)

UF(II) Wide Fixture

K-Number: K173975 · 2018-06-01

Decision Date2018-06-01

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

UF(II) Wide Fixture is a medical device manufactured by Dio Corporation. It received FDA 510(k) clearance on 2018-06-01 under approval number K173975. 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) Wide Fixture?

UF(II) Wide Fixture is a medical device that received FDA 510(k) clearance on 2018-06-01. It is manufactured by Dio Corporation. The 510(k) number is K173975.

When was UF(II) Wide Fixture approved by the FDA?

UF(II) Wide Fixture received FDA 510(k) clearance on 2018-06-01, under approval number K173975.

What company makes UF(II) Wide Fixture?

UF(II) Wide Fixture is manufactured by Dio Corporation.

What is the FDA product code for UF(II) Wide Fixture?

The FDA product code for UF(II) Wide Fixture is DZE.

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 K170608UF(II) Implant System K190048UF(II) Anatomic abutment K193623DIOnavi-Denture

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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.