Cleared Traditional

EXCITE DSC

K003293 · Ivoclar North America, Inc. · Dental
Feb 2001
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K003293 is an FDA 510(k) clearance for the EXCITE DSC, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on February 6, 2001, 109 days after receiving the submission on October 20, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K003293 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2000
Decision Date February 06, 2001
Days to Decision 109 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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