Cleared Traditional

K132450 - CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND

K132450 is an FDA 510(k) clearance for CLEARFIL UNIVERSAL BOND VALUE PACK, 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 87-day FDA review.

K132450 · Kuraray Noritake Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2013
Decision
87d
Days
Class 2
Risk

K132450 is an FDA 510(k) clearance for the CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL .... 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 November 1, 2013 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kuraray Noritake Dental, Inc. devices

FDA 510(k) Submission Details - K132450

510(k) Number K132450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2013
Decision Date November 01, 2013
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
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 K132450.
ADHESE UNIVERSAL
K133318 · Ivoclar Vivadent, AG · Feb 2014
FUSION SINGLE LINK
K132923 · Angelus Industria DE Productos Odontologicos SA · Jan 2014
K-ETCHANT SYRINGE
K133078 · Kuraray Noritake Dental, Inc. · Dec 2013
APEX UNIVERSAL ADHESIVE
K131043 · Apex Dental Materials, Inc. · Sep 2013
PEAK Z
K131357 · Ultradent Products, Inc. · Sep 2013
CLEARFIL DC ACTIVATOR
K131430 · Kuraray Noritake Dental, Inc. · Aug 2013