Cleared Traditional

K160782 - BracePaste Adhesive

K160782 is an FDA 510(k) clearance for BracePaste Adhesive, manufactured by American Orthodontics. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K160782 · American Orthodontics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
206d
Days
Class 2
Risk

K160782 is an FDA 510(k) clearance for the BracePaste Adhesive. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on October 14, 2016 after a review of 206 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 American Orthodontics devices

FDA 510(k) Submission Details - K160782

510(k) Number K160782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2016
Decision Date October 14, 2016
Days to Decision 206 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
79d slower than avg
Panel avg: 127d · This submission: 206d
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 141
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K160782.
GlassLok Kits, GlassLok Powder, GlassLok Liquid
K193388 · Reliance Orthodontic Products, Inc. · Apr 2020
BrackFix
K183147 · Voco GmbH · Mar 2019
OBA-MCP, Orthodontic Bracket Adhesive with MCP
K173020 · Pulpdent Corporation · Jan 2018
Quantum LB
K161684 · Reliance Orthodontic Products, Inc. · Oct 2016
GC Ortho Connect, GC Ortho Etching Gel
K150128 · Gc Orthodontics America, Inc. · Jul 2015
GC KommonBase
K143667 · Gc Orthodontics America, Inc. · May 2015