Cleared Traditional

BEAUTIFIL II

K251578 · Shofu Dental Corporation · Dental
May 2025
Decision
5d
Days
Class 2
Risk

About This 510(k) Submission

K251578 is an FDA 510(k) clearance for the BEAUTIFIL II, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on May 27, 2025, 5 days after receiving the submission on May 22, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K251578 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2025
Decision Date May 27, 2025
Days to Decision 5 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690