Cleared Traditional

ZIRCONOMER P

K252165 · Shofu Dental Corporation · Dental
Oct 2025
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K252165 is an FDA 510(k) clearance for the ZIRCONOMER P, 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 October 28, 2025, 110 days after receiving the submission on July 10, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K252165 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2025
Decision Date October 28, 2025
Days to Decision 110 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