Cleared Traditional

K083304 - TEMPOSIL 2 (FDA 510(k) Clearance)

K083304 · Coltene/Whaledent AG · Dental device
Feb 2009
Decision
88d
Days
Class 2
Risk

K083304 is an FDA 510(k) clearance for the TEMPOSIL 2. 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 February 6, 2009, 88 days after receiving the submission on November 10, 2008.

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

Submission Details

510(k) Number K083304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date February 06, 2009
Days to Decision 88 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