K253501

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);

510(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 BR
Product code: ELW — Material, Impression
Decision date: 2025-10-31
Date received: 2025-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Flag: Third-party review
Advisory committee: Dental

PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain

Also available from FDA: K253501.pdf

Official FDA record: K253501

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.