Cleared Traditional

K142886 - DMRC Self-Cure Bracket Adhesive One Ste...

K142886 is an FDA 510(k) clearance for DMRC Self-Cure Bracket Adhesive One Ste..., manufactured by Danville Materials, LLC. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K142886 · Danville Materials, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2015
Decision
167d
Days
Class 2
Risk

K142886 is an FDA 510(k) clearance for the DMRC Self-Cure Bracket Adhesive One Step and Primer. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Danville Materials, LLC (San Ramon, US). The FDA issued a Cleared decision on March 18, 2015 after a review of 167 days - an extended review 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: 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 Danville Materials, LLC devices

FDA 510(k) Submission Details - K142886

510(k) Number K142886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2014
Decision Date March 18, 2015
Days to Decision 167 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 127d · This submission: 167d
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 133
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K142886.
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K111814 · Reliance Orthodontic Products, Inc. · Sep 2011