Cleared Traditional

K180598 - UNIQA Dental Implants System

K180598 is the FDA 510(k) clearance for UNIQA Dental Implants System by Uniqa Dental, Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K180598 · Uniqa Dental, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
154d
Days
Class 2
Risk

K180598 is an FDA 510(k) clearance for the UNIQA Dental Implants System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Uniqa Dental, Ltd. (Netanya, IL). The FDA issued a Cleared decision on August 8, 2018 after a review of 154 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Uniqa Dental, Ltd. devices

Submission Details

510(k) Number K180598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2018
Decision Date August 08, 2018
Days to Decision 154 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 127d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Sterling Medical Registration
Daniela Levy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K180598.
BTI Dental Implant System UnicCa
K173257 · B.T.I. Biotechnology Institute, Sl. · Aug 2018
OsteoReady Dental Implant System
K173575 · Osteoready, LLC · Aug 2018
MyPlant II Implant System
K173819 · Hager& Meisinger GmbH · Aug 2018
S-mini active Fixture
K181178 · Neobiotech Co., Ltd. · Jul 2018
Zuga Dental Implant System
K171197 · Zuga Medical, Inc. · Jun 2018
KJ ZIRCONIA Implant System
K173116 · Kj Meditech Co., Ltd. · Jun 2018