Cleared Traditional

K042422 - D3 CHROMA

K042422 is an FDA 510(k) clearance for D3 CHROMA, manufactured by Sybron Dental Specialties, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K042422 · Sybron Dental Specialties, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2004
Decision
69d
Days
Class 2
Risk

K042422 is an FDA 510(k) clearance for the D3 CHROMA. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on November 15, 2004 after a review of 69 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 Sybron Dental Specialties, Inc. devices

FDA 510(k) Submission Details - K042422

510(k) Number K042422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2004
Decision Date November 15, 2004
Days to Decision 69 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
58d faster than avg
Panel avg: 127d · This submission: 69d
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 136
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K042422.
THERMA-CURE
K071590 · Reliance Orthodontic Products, Inc. · Jul 2007
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K061481 · Ormco Corp. · Jul 2006
LC BRACKET ADHESIVE SYSTEM
K050750 · Dentsply Intl. · Apr 2005
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375 · Dentsply Intl. · Apr 2004
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
K040547 · Harry J. Bosworth Co. · Mar 2004
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
K040548 · Harry J. Bosworth Co. · Mar 2004