Cleared Traditional

TheraCem

K161256 · Bisco, Inc. · Dental
Jul 2016
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K161256 is an FDA 510(k) clearance for the TheraCem, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 29, 2016, 86 days after receiving the submission on May 4, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K161256 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 2016
Decision Date July 29, 2016
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275