Cleared Traditional

CLEAN AND BOOST

K120620 · Apex Dental Materials, Inc. · Dental
May 2012
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K120620 is an FDA 510(k) clearance for the CLEAN AND BOOST, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on May 31, 2012, 91 days after receiving the submission on March 1, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K120620 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2012
Decision Date May 31, 2012
Days to Decision 91 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