Cleared Traditional

K022224 - COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM

K022224 is an FDA 510(k) clearance for COOL BOND LIGHT CURED BRACKET ADHESIVE ..., manufactured by Coltene AG. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K022224 · Coltene AG · Dental device
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Sep 2002
Decision
70d
Days
Class 2
Risk

K022224 is an FDA 510(k) clearance for the COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Coltene AG (Mahwah, US). The FDA issued a Cleared decision on September 18, 2002 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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 Coltene AG devices

FDA 510(k) Submission Details - K022224

510(k) Number K022224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2002
Decision Date September 18, 2002
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 137
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K022224.
ENVISION
K032042 · Sybron Dental Specialties, Inc. · Sep 2003
S & C -BRACKET ADHESIVES
K031420 · S & C Polymer GmbH · Aug 2003
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
K030036 · Pulpdent Corporation · Mar 2003
SOLO ORTHO 3
K020502 · Sybron Dental Specialties, Inc. · May 2002
GC FUJI ORTHO BAND PASTE PAK
K020578 · GC America, Inc. · Apr 2002
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K014133 · Pulpdent Corp. · Mar 2002