UNIQA® Dental Implants System— 510(k) K251188
Substantially EquivalentUniqa Dental, Ltd.
FDA 510(k) clearance K251188 for UNIQA® Dental Implants System, Substantially Equivalent on 2026-06-25. Applicant: Uniqa Dental, Ltd.. Device class: 2.
Summary
The UNIQA Dental Implants System from Uniqa Dental is filed under DZE, root-form endosseous implants. The record doesn't list implant sizes or models.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
Uniqa filed from Netanya, Israel. Review took 434 calendar days (April 17, 2025 to June 25, 2026).
Clearance details
- Applicant
- Uniqa Dental, Ltd.
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Netanya, IL
Recent devices under product code DZE
view allMore clearances from Uniqa Dental, Ltd.
view allAdverse 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, through . 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.