Cleared Traditional

CERCOM II CEMENT

K132393 · Denali Corporation · Dental
Mar 2014
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K132393 is an FDA 510(k) clearance for the CERCOM II CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Denali Corporation (Hanover, US). The FDA issued a Cleared decision on March 14, 2014, 225 days after receiving the submission on August 1, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K132393 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2013
Decision Date March 14, 2014
Days to Decision 225 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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