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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 the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2017-02-21 under 510(k) 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. The listed applicant is Dio Corporation. The 510(k) number is K161987.

When did UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure receive FDA 510(k) clearance?

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

Who is the listed applicant for UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure?

The FDA 510(k) record lists Dio Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Dio Corporation as applicant

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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