Cleared Traditional

LC ResinCal PC

K202413 · S&C Polymer Silicon- Und Composite Spezialitaten GmbH · Dental
Nov 2020
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K202413 is an FDA 510(k) clearance for the LC ResinCal PC, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by S&C Polymer Silicon- Und Composite Spezialitaten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on November 20, 2020, 88 days after receiving the submission on August 24, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K202413 FDA.gov
FDA Decision Cleared 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

Device Classification

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