Cleared Traditional

K140537 - TENURE4G

K140537 is an FDA 510(k) clearance for TENURE4G, manufactured by Den-Mat Holdings, LLC. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K140537 · Den-Mat Holdings, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
169d
Days
Class 2
Risk

K140537 is an FDA 510(k) clearance for the TENURE4G. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Den-Mat Holdings, LLC (Lompoc, US). The FDA issued a Cleared decision on August 20, 2014 after a review of 169 days - an extended review cycle.

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 Den-Mat Holdings, LLC devices

FDA 510(k) Submission Details - K140537

510(k) Number K140537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2014
Decision Date August 20, 2014
Days to Decision 169 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
42d slower than avg
Panel avg: 127d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLE Device Classification - Class 2, Special Controls

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 318
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K140537.
Monobond Etch & Prime
K150164 · Ivoclar Vivadent, AG · Apr 2015
EAZY PRIMER
K142848 · Parkell, Inc. · Feb 2015
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
ADHESE UNIVERSAL
K133318 · Ivoclar Vivadent, AG · Feb 2014