Cleared Traditional

K253248 - Bright Cavity Liner

K253248 is an FDA 510(k) clearance for Bright Cavity Liner, manufactured by Dmp Dental Industry S.A.. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

K253248 is an FDA 510(k) clearance for the Bright Cavity Liner. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by Dmp Dental Industry S.A. (Markopoulo, GR). The FDA issued a Cleared decision on January 13, 2026 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3250 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dmp Dental Industry S.A. devices

FDA 510(k) Submission Details - K253248

510(k) Number K253248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJK Device Classification - Class 2, Special Controls

Product Code EJK Liner, Cavity, Calcium Hydroxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJK Liner, Cavity, Calcium Hydroxide

All 47
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K253248.
3M™ VitCal Liner/Base
K230270 · 3M Espe Dental Products · Feb 2023
Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)
K212475 · Prevest Denpro Limited · May 2022
CleaniCal
K201799 · Maruchi · Feb 2021
LC ResinCal PC
K202413 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH · Nov 2020
Parkell Desensitizer Gel
K191103 · Parkell, Inc. · Nov 2019
TheraCal DC
K180344 · Bisco, Inc. · Apr 2018