Cleared Traditional

K121621 - SOLOCEM (FDA 510(k) Clearance)

K121621 · Coltene/Whaledent AG · Dental device
Jan 2013
Decision
221d
Days
Class 2
Risk

K121621 is an FDA 510(k) clearance for the SOLOCEM. 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 January 8, 2013, 221 days after receiving the submission on June 1, 2012.

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

Submission Details

510(k) Number K121621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2012
Decision Date January 08, 2013
Days to Decision 221 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