Cleared Traditional

MODIFICATION TO EXCITE

K011490 · Ivoclar North America, Inc. · Dental
Jun 2001
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K011490 is an FDA 510(k) clearance for the MODIFICATION TO EXCITE, 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 June 27, 2001, 43 days after receiving the submission on May 15, 2001. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K011490 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2001
Decision Date June 27, 2001
Days to Decision 43 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