Cleared Traditional

K131430 - CLEARFIL DC ACTIVATOR

Also marketed or referenced as:
CLEARFIL DC ACTIVATOR TRIAL

K131430 is the FDA 510(k) clearance for CLEARFIL DC ACTIVATOR by Kuraray Noritake Dental, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K131430 · Kuraray Noritake Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
105d
Days
Class 2
Risk

K131430 is an FDA 510(k) clearance for the CLEARFIL DC ACTIVATOR. 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 30, 2013 after a review of 105 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

Submission Details

510(k) Number K131430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2013
Decision Date August 30, 2013
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
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 249
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K131430.
FUTURABOND M+
K141610 · Voco GmbH · Aug 2014
ALL-BOND UNIVERSAL SC (NOT FINALIZED)
K131734 · Bisco, Inc. · Apr 2014
PEAK Z
K131357 · Ultradent Products, Inc. · Sep 2013
PREMIER CERAMIC PRIMER
K131212 · Premier Dental Products Co. · Aug 2013
FUTURABOND UNIVERSAL
K130486 · Voco GmbH · Jun 2013
CERARESIN BOND
K123119 · Shofu Dental Corporation · Nov 2012