Cleared Abbreviated

K120619 - ORTHODONTIC FLOWABLE BRACKET ADHESIVE

K120619 is an FDA 510(k) clearance for ORTHODONTIC FLOWABLE BRACKET ADHESIVE, manufactured by Novocol, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Abbreviated 510(k) pathway after a 82-day FDA review.

K120619 · Novocol, Inc. · Dental device
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May 2012
Decision
82d
Days
Class 2
Risk

K120619 is an FDA 510(k) clearance for the ORTHODONTIC FLOWABLE BRACKET ADHESIVE. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Novocol, Inc. (Louisville, US). The FDA issued a Cleared decision on May 21, 2012 after a review of 82 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Novocol, Inc. devices

FDA 510(k) Submission Details - K120619

510(k) Number K120619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2012
Decision Date May 21, 2012
Days to Decision 82 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Standards-based clearance path.

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 K120619.
BracePaste Adhesive
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K161684 · Reliance Orthodontic Products, Inc. · Oct 2016
CLEAR ALIGNER ADHESIVE
K123348 · Reliance Orthodontic Products, Inc. · Feb 2013
ORTHO-1(NOT FINALIZED)
K113401 · Bisco, Inc. · Feb 2012
PADLOCK
K111814 · Reliance Orthodontic Products, Inc. · Sep 2011
OPAL BAND CEMENT
K111696 · Ultradent Products, Inc. · Sep 2011