Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more— 510(k) K253501

Name: FDA 510(k) clearance K253501
Creator: U.S. Food and Drug Administration
Published: 2025-10-31

Substantially Equivalent

Vigodent Indústria E Comercio Ltda

FDA 510(k) clearance K253501 for Hydro Print Premium Fast Set - 454g (1lb) (052037) +9 more, Substantially Equivalent on 2025-10-31. Applicant: Vigodent Indústria E Comercio Ltda. Device class: 2.

Clearance details

Device name as filed: 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: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2025-10-30
Decision date: 2025-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rio De Janeiro, BR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.