Cleared Traditional

TheraCal DC

K143292 · Bisco, Inc. · Dental
Aug 2015
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K143292 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 August 4, 2015, 260 days after receiving the submission on November 17, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3250.

Submission Details

510(k) Number K143292 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 2014
Decision Date August 04, 2015
Days to Decision 260 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

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