510(k) K252145 · DZE Implant, Endosseous, Root-Form
GEN5 and GEN5+ 3.3mmD Dental Implants
| Applicant | Paragon Implant Mfg., LLC, Calabasas CA, US |
| Decision | Substantially Equivalent, Dec 23, 2025 |
| Received | Jul 9, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252145
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.