Cleared Special

TheraCal DC

K180344 · Bisco, Inc. · Dental
Apr 2018
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K180344 is an FDA 510(k) clearance for the TheraCal DC, a Liner, Cavity, Calcium Hydroxide (Class II — Special Controls, product code EJK), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on April 5, 2018, 56 days after receiving the submission on February 8, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K180344 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 2018
Decision Date April 05, 2018
Days to Decision 56 days
Submission Type Special
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

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