Cleared Traditional

K251470 - ResiCem EX (FDA 510(k) Clearance)

K251470 · Shofu Dental Corporation · Dental device
Jul 2025
Decision
59d
Days
Class 2
Risk

K251470 is an FDA 510(k) clearance for the ResiCem EX. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on July 11, 2025, 59 days after receiving the submission on May 13, 2025.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K251470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2025
Decision Date July 11, 2025
Days to Decision 59 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