510(k) K203382 ยท DZE Implant, Endosseous, Root-Form
Neodent Implant System-Easy Pack
| Applicant | Jjgc Industria E Comercio DE Materiais Dentarios S.A., Curitiba, BR |
| Decision | Substantially Equivalent, Mar 15, 2021 |
| Received | Nov 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203382
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2021 | Straumann USA LLC Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant
Item 138.089 Terminated |
DZE | None listed |
| Nov 30, 2021 | Straumann USA LLC Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5
Article Number: 138.107 Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.