Cleared Traditional

RODIN Cement

K251775 · Belport Company, Inc., Gingi-Pak · Dental
Sep 2025
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K251775 is an FDA 510(k) clearance for the RODIN Cement, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on September 2, 2025, 84 days after receiving the submission on June 10, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K251775 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 2025
Decision Date September 02, 2025
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275