K251938
- 510(k) number
- K251938
- Device name
- GEN5 and GEN5+ Dental Implant System
- Applicant
- Paragon Implant Mfg., LLC CA · US
- Product code
- DZE — Implant, Endosseous, Root-Form
- Decision date
- 2025-10-30
- Date received
- 2025-06-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K251938.pdf
Official FDA record: K251938
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.