Cleared Traditional

EXCITE F AND EXCITE DSC

K093744 · Ivoclar Vivadent, Inc. · Dental
Mar 2010
Decision
96d
Days
Class 2
Risk

About This 510(k) Submission

K093744 is an FDA 510(k) clearance for the EXCITE F AND EXCITE DSC, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on March 10, 2010, 96 days after receiving the submission on December 4, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K093744 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2009
Decision Date March 10, 2010
Days to Decision 96 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200