Vigodent Indústria E Comercio Ltda · Class II · Cleared Oct 31, 2025
| K-number | K253501 |
| Device name | 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 Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); |
| Applicant | Vigodent Indústria E Comercio Ltda |
| Product code | ELW |
| Device class | Class II |
| Decision date | Oct 31, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 872.3660 |
The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →
View the full FDA submission: accessdata.fda.gov