FDA cleared 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); from Vigodent Indústria E Comercio Ltda on Oct 31, 2025 under K253501, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code ELW, Material, Impression, regulated at 21 CFR 872.3660 as a Class 2 device. The review panel was Dental.
FDA logged the submission as received on Oct 30, 2025. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).
This is the only decision on file for Vigodent Indústria E Comercio Ltda in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K253501?
K253501 is the FDA 510(k) for 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);, submitted by Vigodent Indústria E Comercio Ltda. FDA's decision date was Oct 31, 2025, under product code ELW (Material, Impression).
Who makes 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);?
Vigodent Indústria E Comercio Ltda, based in Rio De Janeiro, is the applicant of record for K253501.
How long did the K253501 review take?
FDA received the submission on Oct 30, 2025 and issued its decision on Oct 31, 2025, 1 days later.