Cleared Traditional

K111975 - CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK

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

K111975 · Kuraray Medical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K111975

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.

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 370
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K111975.
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K112118 · Bisco, Inc. · Nov 2011
CLEARFIL TRI-S BOND PLUS
K111980 · Kuraray America, Inc. · Oct 2011
Z BOND, PRELUDE ONE
K111876 · Danville Materials, Inc. · Sep 2011
PROLINK ADHESIVES (PROLINK, PROLINK SE)
K110403 · Silmet , Ltd. · Sep 2011