510(k) K253501 · ELW Material, Impression
Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chro
| Applicant | Vigodent Indústria E Comercio Ltda, Rio De Janeiro, BR |
| Decision | Substantially Equivalent, Oct 31, 2025 |
| Received | Oct 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253501
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.