Cleared Traditional

K042913 - CLEARFIL TRI-S BOND

K042913 is an FDA 510(k) clearance for CLEARFIL TRI-S BOND, 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 36-day FDA review.

K042913 · Kuraray Medical, Inc. · Dental device
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Nov 2004
Decision
36d
Days
Class 2
Risk

K042913 is an FDA 510(k) clearance for the CLEARFIL TRI-S BOND. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Kuraray Medical, Inc. (New York, US). The FDA issued a Cleared decision on November 26, 2004 after a review of 36 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 Medical, Inc. devices

FDA 510(k) Submission Details - K042913

510(k) Number K042913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2004
Decision Date November 26, 2004
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
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 371
Devices cleared under the same product code (KLE) and FDA review panel - the closest regulatory comparables to K042913.
PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM
K050386 · Dentsply International · Feb 2005
HERMES BOND 2
K043043 · 3M Espe AG Dental Products · Jan 2005
BC PLUS
K043562 · Vericom Co., Ltd. · Jan 2005
QUADRANT UNIT-1-BOND
K042806 · Cavex Holland BV · Nov 2004
S&C-SELF ETCH PR-BOND
K042614 · S & C Polymer GmbH · Nov 2004
ORAJEL ADVANCED TOOTH DESENSITIZER
K041680 · Del Pharmaceuticals, Inc. · Nov 2004