UNIQA Dental Implants System— 510(k) K180598

Name: FDA 510(k) clearance K180598
Creator: U.S. Food and Drug Administration
Published: 2018-08-08

Substantially Equivalent

Uniqa Dental, Ltd.

FDA 510(k) clearance K180598 for UNIQA Dental Implants System, Substantially Equivalent on 2018-08-08. Applicant: Uniqa Dental, Ltd.. Device class: 2.

Clearance details

Applicant: Uniqa Dental, Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2018-03-07
Decision date: 2018-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

view all

K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.