Cleared Traditional

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 · Vigodent Ind?stria E Comercio Ltda · Dental

Oct 2025

Decision

Days

Class 2

Risk

About This 510(k) Submission

K253501 is an FDA 510(k) clearance for the 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);, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Vigodent Ind?stria E Comercio Ltda (Rio De Janeiro, BR). The FDA issued a Cleared decision on October 31, 2025, 1 days after receiving the submission on October 30, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number	K253501 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 30, 2025
Decision Date	October 31, 2025
Days to Decision	1 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF