Cleared Traditional

Bright Cavity Liner

K253248 · Dmp Dental Industry S.A. · Dental
Jan 2026
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K253248 is an FDA 510(k) clearance for the Bright Cavity Liner, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by Dmp Dental Industry S.A. (Markopoulo, GR). The FDA issued a Cleared decision on January 13, 2026, 106 days after receiving the submission on September 29, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K253248 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2025
Decision Date January 13, 2026
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJK — Liner, Cavity, Calcium Hydroxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3250