UNIQA Dental Implants System

FDA 510(k) K180598 · Uniqa Dental, Ltd.

Substantially Equivalent

510(k) numberK180598

Submission

Device name
UNIQA Dental Implants System
Applicant
Uniqa Dental, Ltd.
Netanya, IL
Received
March 7, 2018
Decision date
August 8, 2018
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

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K252031Adin Long Dental Implant SystemDZE · Traditional Adin Dental Implant Systems , Ltd.03/23/2026SE
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K252168Straumann® BLC Implants - Indication WideningDZE · Traditional Institut Straumann AG03/10/2026SE
K253493Dentis SQ-SL AXEL FixtureDZE · Traditional Dentis Co., Ltd.03/04/2026SE

More from Dentis Co., Ltd.

510(k)DeviceDecision
K251188UNIQA® Dental Implants SystemDZE · Traditional 06/25/2026SE

Questions and answers

When was UNIQA Dental Implants System cleared by the FDA?

UNIQA Dental Implants System (K180598) received a 510(k) decision of Substantially Equivalent on August 8, 2018, 154 days after the submission was received.

What is the product code of K180598?

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