UNIQA® Dental Implants System

FDA 510(k) K251188 · Uniqa Dental, Ltd.

Substantially Equivalent

510(k) numberK251188

Submission

Device name
UNIQA® Dental Implants System
Applicant
Uniqa Dental, Ltd.
Netanya, IL
Received
April 17, 2025
Decision date
June 25, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DZE – Implant, Endosseous, Root-Form
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3640
Specialty
Dental
Implant
Yes

Other 510(k)s with product code DZE

510(k)DeviceApplicantDecision
K260463ZEROS Dental Implant SystemDZE · Special Zeros Co., Ltd.08/19/2026SE
K251232MegaGen Zygoma Dental Implant SystemDZE · Traditional Megagen Implant Co., Ltd.06/18/2026SE
K250806Dental Implant SystemDZE · Traditional A.B. Dental Devices , Ltd.06/18/2026SE
K260006INOSS SystemDZE · Traditional Inosys, Inc.06/17/2026SE
K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantDZE · Traditional Promimic AB05/12/2026SE
K252031Adin Long Dental Implant SystemDZE · Traditional Adin Dental Implant Systems , Ltd.03/23/2026SE
K253334ZENEX Implant System_Short (R-System)DZE · Traditional Izenimplant Co., Ltd.03/16/2026SE
K252168Straumann® BLC Implants - Indication WideningDZE · Traditional Institut Straumann AG03/10/2026SE
K253493Dentis SQ-SL AXEL FixtureDZE · Traditional Dentis Co., Ltd.03/04/2026SE
K252197Nobel Biocare S Series ImplantsDZE · Traditional Nobel Biocare AB02/18/2026SE

More from Nobel Biocare AB

510(k)DeviceDecision
K180598UNIQA Dental Implants SystemDZE · Traditional 08/08/2018SE

Questions and answers

When was UNIQA® Dental Implants System cleared by the FDA?

UNIQA® Dental Implants System (K251188) received a 510(k) decision of Substantially Equivalent on June 25, 2026, 434 days after the submission was received.

What is the product code of K251188?

The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.