Cleared Special

ALL-BOUND 3

K102844 · Bisco, Inc. · Dental
Oct 2010
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K102844 is an FDA 510(k) clearance for the ALL-BOUND 3, 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 October 29, 2010, 30 days after receiving the submission on September 29, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K102844 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2010
Decision Date October 29, 2010
Days to Decision 30 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