Cleared Traditional

K141047 - LC CALCIUMHYDROXIDE LINER

K141047 is an FDA 510(k) clearance for LC CALCIUMHYDROXIDE LINER, manufactured by S&C Polymer Silicon- Und Composite Spezialitaeten. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K141047 · S&C Polymer Silicon- Und Composite Spezialitaeten · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K141047

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.

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 54
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K141047.
Parkell Desensitizer Gel
K191103 · Parkell, Inc. · Nov 2019
TheraCal DC
K180344 · Bisco, Inc. · Apr 2018
TheraCal DC
K143292 · Bisco, Inc. · Aug 2015
BASE IT
K134022 · Spident Co., Ltd. · Jun 2014
TEETHMATE DESENSITIZER SET
K131068 · Kuraray Noritake Dental, Inc. · Aug 2013
TEETHMATE DESENSITZER SET TEETHMATE DESENSITIZER POWDER TEETHMATE DESENSITIZER LIQUID
K122421 · Kuraray Noritake Dental, Inc. · Dec 2012