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FDA 510(k)

UNIQA® Dental Implants System

K-Number: K251188 · 2026-06-25

ApplicantUniqa Dental, Ltd.
Decision Date2026-06-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNIQA® Dental Implants System is the device name listed in this FDA 510(k) record. The listed applicant is Uniqa Dental, Ltd.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K251188. 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 UNIQA® Dental Implants System?

UNIQA® Dental Implants System is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Uniqa Dental, Ltd.. The 510(k) number is K251188.

When did UNIQA® Dental Implants System receive FDA 510(k) clearance?

UNIQA® Dental Implants System received FDA 510(k) clearance on 2026-06-25, under 510(k) number K251188.

Who is the listed applicant for UNIQA® Dental Implants System?

The FDA 510(k) record lists Uniqa Dental, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UNIQA® Dental Implants System?

The FDA product code for UNIQA® Dental Implants System is DZE.

Other records listing Uniqa Dental, Ltd. 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.

K180598UNIQA Dental Implants System

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.

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.K253334ZENEX Implant System_Short (R-System)Izenimplant 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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