Cleared Traditional

K160443 - TempoCem Clear
(FDA 510(k) Clearance)

K160443 · Dmg USA, Inc. · Dental
Sep 2016
Decision
226d
Days
Class 2
Risk

K160443 is an FDA 510(k) clearance for the TempoCem Clear, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Dmg USA, Inc. (Attleboro, US). The FDA issued a Cleared decision on September 30, 2016, 226 days after receiving the submission on February 17, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K160443 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2016
Decision Date September 30, 2016
Days to Decision 226 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