Cleared Traditional

K131043 - APEX UNIVERSAL ADHESIVE

K131043 is the FDA 510(k) clearance for APEX UNIVERSAL ADHESIVE by Apex Dental Materials, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K131043 · Apex Dental Materials, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
148d
Days
Class 2
Risk

K131043 is an FDA 510(k) clearance for the APEX UNIVERSAL ADHESIVE. 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 September 10, 2013 after a review of 148 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 K131043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2013
Decision Date September 10, 2013
Days to Decision 148 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
21d slower than avg
Panel avg: 127d · This submission: 148d
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 K131043.
PREMIER ETCH
K141839 · Premier Dental Products Co. · Nov 2014
FUTURABOND M+
K141610 · Voco GmbH · Aug 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · Bisco, Inc. · Apr 2014
PEAK Z
K131357 · Ultradent Products, Inc. · Sep 2013
PREMIER CERAMIC PRIMER
K131212 · Premier Dental Products Co. · Aug 2013
FUTURABOND UNIVERSAL
K130486 · Voco GmbH · Jun 2013