Cleared Traditional

K202413 - LC ResinCal PC

K202413 is an FDA 510(k) clearance for LC ResinCal PC, manufactured by S&C Polymer Silicon- Und Composite Spezialitaten GmbH. The device is a Class 2 Dental device with product code EJK cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K202413 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH · Dental device
Download Printable Device Report (PDF)
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Nov 2020
Decision
88d
Days
Class 2
Risk

K202413 is an FDA 510(k) clearance for the LC ResinCal PC. Classified as Liner, Cavity, Calcium Hydroxide (product code EJK), Class II - Special Controls.

Submitted by S&C Polymer Silicon- Und Composite Spezialitaten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on November 20, 2020 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all S&C Polymer Silicon- Und Composite Spezialitaten GmbH devices

FDA 510(k) Submission Details - K202413

510(k) Number K202413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2020
Decision Date November 20, 2020
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 48
Devices cleared under the same product code (EJK) and FDA review panel - the closest regulatory comparables to K202413.
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
Parkell Desensitizer Gel
K191103 · Parkell, Inc. · Nov 2019
TheraCal DC
K180344 · Bisco, Inc. · Apr 2018
TheraCal DC
K143292 · Bisco, Inc. · Aug 2015