Cleared Traditional

Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)

K253053 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Dental
Sep 2025
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K253053 is an FDA 510(k) clearance for the Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1), a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Hangzhou SHINING3D Dental Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on September 23, 2025, 1 days after receiving the submission on September 22, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K253053 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2025
Decision Date September 23, 2025
Days to Decision 1 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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