Class Class II
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); (K253501)
Description
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); by Vigodent Indústria E Comercio Ltda, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK253501
Clearance Date2025-10-31
Clearance TypeTraditional
Product CodeELW
Regulation Number872.3660