510(k) K222231 ยท DZE Implant, Endosseous, Root-Form
S.I.N. Dental Implant System
| Applicant | S.I.N. - Sistema DE Implante Nacional S.A., Sao Paulo, BR |
| Decision | Substantially Equivalent, Oct 27, 2022 |
| Received | Jul 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222231
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 15, 2025 | SIN SISTEMA DE IMPLANTE NACIONAL S.A Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N Open, Classified |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.