Cleared Traditional

K160800 - DuoCem (FDA 510(k) Clearance)

K160800 · Coltene/Whaledent AG · Dental device
Nov 2016
Decision
238d
Days
Class 2
Risk

K160800 is an FDA 510(k) clearance for the DuoCem. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Coltene/Whaledent AG (Altstatten, CH). The FDA issued a Cleared decision on November 16, 2016, 238 days after receiving the submission on March 23, 2016.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K160800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2016
Decision Date November 16, 2016
Days to Decision 238 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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