Cleared Traditional

COLTOSOL F

K031752 · Coltene/Whaledent, Inc. · Dental
Aug 2003
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K031752 is an FDA 510(k) clearance for the COLTOSOL F, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Coltene/Whaledent, Inc. (Cuyahoga Falls, US). The FDA issued a Cleared decision on August 5, 2003, 61 days after receiving the submission on June 5, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K031752 FDA.gov
FDA Decision Cleared SESE
Date Received June 05, 2003
Decision Date August 05, 2003
Days to Decision 61 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