Cleared Traditional

DREAMBOND

K112118 · Bisco, Inc. · Dental
Nov 2011
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K112118 is an FDA 510(k) clearance for the DREAMBOND, 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 November 17, 2011, 115 days after receiving the submission on July 25, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K112118 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2011
Decision Date November 17, 2011
Days to Decision 115 days
Submission Type Traditional
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