Cleared Traditional

K131432 - CLEARFIL SE BOND 2 KIT

Also marketed or referenced as:
CLEARFIL SE BOND 2 VALUE PACK CLEARFIL SE BOND 2 TRIAL PACK CLEARFIL SE BOND 2 BOND CLEARFIL

K131432 is an FDA 510(k) clearance for CLEARFIL SE BOND 2 KIT, manufactured by Kuraray Noritake Dental, Inc.. The device is a Class 2 Dental device with product code KLE cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K131432 · Kuraray Noritake Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
97d
Days
Class 2
Risk

K131432 is an FDA 510(k) clearance for the CLEARFIL SE BOND 2 KIT. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kuraray Noritake Dental, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on August 22, 2013 after a review of 97 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 Kuraray Noritake Dental, Inc. devices

FDA 510(k) Submission Details - K131432

510(k) Number K131432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2013
Decision Date August 22, 2013
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 127d · This submission: 97d
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 374
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K131432.
CLEARFIL DC ACTIVATOR
K131430 · Kuraray Noritake Dental, Inc. · Aug 2013
ZRP
K131049 · Apex Dental Materials, Inc. · Aug 2013
PREMIER CERAMIC PRIMER
K131212 · Premier Dental Products Co. · Aug 2013
ETCH GEL
K131248 · Dmg America, LLC · Jul 2013
FUTURABOND UNIVERSAL
K130486 · Voco GmbH · Jun 2013
DENTOETCH QUICKBOND BOND ACTIVATOR
K122522 · Itena Clinical · Mar 2013