Cleared Traditional

DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) (K013542) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K013542 · Jeneric/Pentron, Inc. · Dental device
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Feb 2002
Decision
120d
Days
Class 2
Risk

K013542 is an FDA 510(k) clearance for the DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1). Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on February 14, 2002 after a review of 120 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 Jeneric/Pentron, Inc. devices

Submission Details

510(k) Number K013542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2001
Decision Date February 14, 2002
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
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 122
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K013542.
XENO III DENTAL ADHESIVE
K023776 · Dentsply Intl. · Jan 2003
IBOND GLUMA INSIDE
K022612 · Heraeus Kulzer, Inc. · Oct 2002
UNIFIL BOND
K013997 · GC America, Inc. · Feb 2002
MODIFICATION TO EXCITE
K011490 · Ivoclar North America, Inc. · Jun 2001
XSE
K011167 · 3M Company · May 2001
EXCITE DSC
K003293 · Ivoclar North America, Inc. · Feb 2001