Cleared Traditional

K111975 - CLEARFIL TRI-S BOND PLUS SINGLE DOSE ST...

K111975 is the FDA 510(k) clearance for CLEARFIL TRI-S BOND PLUS SINGLE DOSE ST... by Kuraray Medical, Inc.. It is a Class 2 Dental device (product code KLE) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K111975 · Kuraray Medical, Inc. · Dental device
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Oct 2011
Decision
94d
Days
Class 2
Risk

K111975 is an FDA 510(k) clearance for the CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kuraray Medical, Inc. (Chiyoda-Ku, Tokyo, JP). The FDA issued a Cleared decision on October 14, 2011 after a review of 94 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 Medical, Inc. devices

Submission Details

510(k) Number K111975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2011
Decision Date October 14, 2011
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
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 248
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K111975.
FUTURABOND UNIVERSAL
K130486 · Voco GmbH · Jun 2013
CERARESIN BOND
K123119 · Shofu Dental Corporation · Nov 2012
DREAMBOND
K112118 · Bisco, Inc. · Nov 2011
BEAUTIBOND MULTI
K110235 · Shofu Dental Corp. · May 2011
BEAUTIBOND MULTI PR PLUS
K110252 · Shofu Dental Corp. · May 2011
ALL-BOUND 3
K102844 · Bisco, Inc. · Oct 2010