Cleared Traditional

K072604 - DUO TEMP (FDA 510(k) Clearance)

K072604 · Coltene/Whaledent AG · Dental device
Nov 2007
Decision
60d
Days
Class 2
Risk

K072604 is an FDA 510(k) clearance for the DUO TEMP. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Coltene/Whaledent AG (New York, US). The FDA issued a Cleared decision on November 16, 2007, 60 days after receiving the submission on September 17, 2007.

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

Submission Details

510(k) Number K072604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2007
Decision Date November 16, 2007
Days to Decision 60 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