Cleared Traditional

K033760 - ONE COAT SE BOND
(FDA 510(k) Clearance)

K033760 · Coltene/Whaledent, Inc. · Dental
Jan 2004
Decision
52d
Days
Class 2
Risk

K033760 is an FDA 510(k) clearance for the ONE COAT SE BOND, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Coltene/Whaledent, Inc. (New York, US). The FDA issued a Cleared decision on January 23, 2004, 52 days after receiving the submission on December 2, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K033760 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2003
Decision Date January 23, 2004
Days to Decision 52 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