Cleared Traditional

Denture Base Resin DT20

K250946 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Dental
Mar 2025
Decision
3d
Days
Class 2
Risk

About This 510(k) Submission

K250946 is an FDA 510(k) clearance for the Denture Base Resin DT20, a Resin, Denture, Relining, Repairing, Rebasing (Class II — Special Controls, product code EBI), submitted by Hangzhou SHINING3D Dental Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 31, 2025, 3 days after receiving the submission on March 28, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3760.

Submission Details

510(k) Number K250946 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2025
Decision Date March 31, 2025
Days to Decision 3 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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