Cleared Traditional

TEMP MASTER, PMMA-based dental resin

K243951 · Taiwan Dental Materials Co., Ltd. · Dental
Feb 2025
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K243951 is an FDA 510(k) clearance for the TEMP MASTER, PMMA-based dental resin, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Taiwan Dental Materials Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on February 21, 2025, 60 days after receiving the submission on December 23, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K243951 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2024
Decision Date February 21, 2025
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBG — Crown And Bridge, Temporary, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3770