Cleared Traditional

K120620 - CLEAN AND BOOST

K120620 is the FDA 510(k) clearance for CLEAN AND BOOST by Apex Dental Materials, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

K120620 is an FDA 510(k) clearance for the CLEAN AND BOOST. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on May 31, 2012 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Apex Dental Materials, Inc. devices

Submission Details

510(k) Number K120620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - KLE Agent, Tooth Bonding, Resin

All 249
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K120620.
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K110235 · Shofu Dental Corp. · May 2011