Cleared Traditional

LuxCreo Flexible Partial Denture Resin

K253365 · LuxCreo, Inc. · Dental
Nov 2025
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K253365 is an FDA 510(k) clearance for the LuxCreo Flexible Partial Denture Resin, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by LuxCreo, Inc. (Chicago, US). The FDA issued a Cleared decision on November 25, 2025, 56 days after receiving the submission on September 30, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K253365 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2025
Decision Date November 25, 2025
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBI — Resin, Denture, Relining, Repairing, Rebasing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3760

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