Cleared Traditional

K122522 - DENTOETCH QUICKBOND BOND ACTIVATOR

K122522 is an FDA 510(k) clearance for DENTOETCH QUICKBOND BOND ACTIVATOR, manufactured by Itena Clinical. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K122522 · Itena Clinical · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
211d
Days
Class 2
Risk

K122522 is an FDA 510(k) clearance for the DENTOETCH QUICKBOND BOND ACTIVATOR. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Itena Clinical (Laval, CA). The FDA issued a Cleared decision on March 19, 2013 after a review of 211 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 Itena Clinical devices

FDA 510(k) Submission Details - K122522

510(k) Number K122522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2012
Decision Date March 19, 2013
Days to Decision 211 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
84d slower than avg
Panel avg: 127d · This submission: 211d
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 336
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K122522.
PREMIER CERAMIC PRIMER
K131212 · Premier Dental Products Co. · Aug 2013
CLEARFIL SE BOND 2 KIT
K131432 · Kuraray Noritake Dental, Inc. · Aug 2013
FUTURABOND UNIVERSAL
K130486 · Voco GmbH · Jun 2013
CERARESIN BOND
K123119 · Shofu Dental Corporation · Nov 2012
ETCH-RITE SUPREME
K120213 · Pulpdent Corporation · Mar 2012
DREAMBOND
K112118 · Bisco, Inc. · Nov 2011