510(k) K223697 ยท DZE Implant, Endosseous, Root-Form
MRI compatibility for existing BioHorizons dental implants and abutments
| Applicant | BioHorizons Implant Systems, Inc., Birmingham AL, US |
| Decision | Substantially Equivalent, Oct 13, 2023 |
| Received | Dec 9, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223697
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2025 | DDS Lab Temporary Titanium Abutments Open, Classified |
NHA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.