Cleared Traditional

TempFIT Temporary Crown and Bridge Resin

K251271 · Rizhao Huge Biomaterials Company, Ltd. · Dental
Jun 2025
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K251271 is an FDA 510(k) clearance for the TempFIT Temporary Crown and Bridge Resin, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Rizhao Huge Biomaterials Company, Ltd. (Rizhao, CN). The FDA issued a Cleared decision on June 23, 2025, 60 days after receiving the submission on April 24, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number K251271 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2025
Decision Date June 23, 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