Cleared Traditional

K141047 - LC CALCIUMHYDROXIDE LINER (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K141047 · S&C Polymer Silicon- Und Composite Spezialitaeten · Dental device
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Apr 2015
Decision
356d
Days
Class 2
Risk

K141047 is an FDA 510(k) clearance for the LC CALCIUMHYDROXIDE LINER. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by S&C Polymer Silicon- Und Composite Spezialitaeten (Elmshorn, Schleswig-Holstein, DE). The FDA issued a Cleared decision on April 14, 2015 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 S&C Polymer Silicon- Und Composite Spezialitaeten devices

Submission Details

510(k) Number K141047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2014
Decision Date April 14, 2015
Days to Decision 356 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 127d · This submission: 356d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 76
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K141047.
Bright Cavity Liner
K253248 · Dmp Dental Industry S.A. · Jan 2026
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