Cleared Abbreviated

K120619 - ORTHODONTIC FLOWABLE BRACKET ADHESIVE (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K120619 · Novocol, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 191
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K120619.
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive
K250015 · Ormco Corporation · Jan 2025
BracePaste Fluoride Sealant
K242537 · American Orthodontics Corp. · Aug 2024
3M™ Transbond™ Orthodontic Adhesive
K234043 · 3M Unitek Orthodontic Products · Dec 2023
AlignerFlow LC
K231817 · Voco GmbH · Dec 2023
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
K214054 · Tp Orthodontics, Inc. · Oct 2022
FiteBac CC OrthoSeal
K210115 · Largent Health, LLC · Jul 2021