510(k) K253959 ยท OAS X-Ray, Tomography, Computed, Dental
Primevision 3D
| Applicant | Dentsply Sirona, York PA, US |
| Decision | Substantially Equivalent, Feb 5, 2026 |
| Received | Dec 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253959
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.