Cleared Special

ACE BOND SE

K063780 · Bisco, Inc. · Dental
Jan 2007
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K063780 is an FDA 510(k) clearance for the ACE BOND SE, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on January 19, 2007, 29 days after receiving the submission on December 21, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K063780 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2006
Decision Date January 19, 2007
Days to Decision 29 days
Submission Type Special
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