Cleared Traditional

AURAVENEER CEMENT

K073101 · Denali Corporation · Dental
Jan 2008
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K073101 is an FDA 510(k) clearance for the AURAVENEER CEMENT, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Denali Corporation (Hanover, US). The FDA issued a Cleared decision on January 17, 2008, 93 days after receiving the submission on October 16, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K073101 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 2007
Decision Date January 17, 2008
Days to Decision 93 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