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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 the device name listed in this FDA 510(k) record. The listed applicant is Dio Corporation. It received FDA 510(k) clearance on 2018-03-30 under 510(k) 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. The listed applicant is Dio Corporation. The 510(k) number is K170608.

When did UF(II) Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for UF(II) Implant System?

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) Implant System?

The FDA product code for UF(II) Implant System is DZE.

Other records listing Dio Corporation as applicant

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.

K220253Eco Abutment, Multiunit AbutmentK210828DIOnavi-Denture02K193623DIOnavi-DentureK193404UF(II) Bar holder abutmentK192263UCLA CCM AbutmentK190048UF(II) Anatomic abutment

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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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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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