K250476
- 510(k) number
- K250476
- Device name
- NizPlant Dental Implant System
- Applicant
- Paragon Implant Mfg., LLC CA · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-12-23
- Date received
- 2025-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K250476.pdf
Official FDA record: K250476
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.