Cleared Traditional

EXCITE

K990534 · Ivoclar North America, Inc. · Dental
Mar 1999
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K990534 is an FDA 510(k) clearance for the 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 March 19, 1999, 28 days after receiving the submission on February 19, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K990534 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 1999
Decision Date March 19, 1999
Days to Decision 28 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