NizPlant Dental Implant System— 510(k) K250476

Substantially Equivalent

Paragon Implant Mfg., LLC

FDA 510(k) clearance K250476 for NizPlant Dental Implant System, Substantially Equivalent on 2025-12-23. Applicant: Paragon Implant Mfg., LLC.

Clearance details

Applicant: Paragon Implant Mfg., LLC
Product code: Code DZE
Advisory panel: Dental
Date received: 2025-02-19
Decision date: 2025-12-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Calabasas, CA, US

Download summary PDF View on FDA.gov ↗

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.