DYH · Class II · 21 CFR 872.3750

FDA Product Code DYH: Adhesive, Bracket And Tooth Conditioner, Resin

Leading manufacturers include Reliance Orthodontic Products, Inc., Sybron Dental Specialties, Inc. and Ormco Corp..

194
Total
194
Cleared
80d
Avg days
1976
Since
Declining activity - 3 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 30d recently vs 81d historically

FDA 510(k) Cleared Adhesive, Bracket And Tooth Conditioner, Resin Devices (Product Code DYH)

194 devices
1–24 of 194
Cleared Jul 02, 2026
OrthoFit
K261129
Spident Co., Ltd.
Dental · 87d
Cleared Jun 03, 2026
BracePaste Prime Plus
K261840
American Orthodontics
Dental · 1d
Cleared Jan 03, 2025
Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive
K250015
Ormco Corporation
Dental · 1d
Cleared Aug 27, 2024
BracePaste Fluoride Sealant
K242537
American Orthodontics Corp.
Dental · 1d
Cleared Dec 22, 2023
3M™ Transbond™ Orthodontic Adhesive
K234043
3M Unitek Orthodontic Products
Dental · 1d
Cleared Dec 01, 2023
AlignerFlow LC
K231817
Voco GmbH
Dental · 163d
Cleared Oct 14, 2022
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
K214054
Tp Orthodontics, Inc.
Dental · 291d
Cleared Jul 29, 2021
FiteBac CC OrthoSeal
K210115
Largent Health, LLC
Dental · 191d
Cleared Aug 14, 2020
Orthocem, Ortho Bite
K192682
Dentscare Ltda
Dental · 323d
Cleared Aug 14, 2020
BracePaste Band and Build LC
K202276
American Orthodontics
Dental · 3d
Cleared Apr 27, 2020
GlassLok Kits, GlassLok Powder, GlassLok Liquid
K193388
Reliance Orthodontic Products, Inc.
Dental · 143d
Cleared Mar 01, 2019
BrackFix
K183147
Voco GmbH
Dental · 108d
Cleared Jan 17, 2018
OBA-MCP, Orthodontic Bracket Adhesive with MCP
K173020
Pulpdent Corporation
Dental · 111d
Cleared Oct 14, 2016
BracePaste Adhesive
K160782
American Orthodontics
Dental · 206d
Cleared Oct 06, 2016
Quantum LB
K161684
Reliance Orthodontic Products, Inc.
Dental · 111d
Cleared Jul 16, 2015
GC Ortho Connect, GC Ortho Etching Gel
K150128
Gc Orthodontics America, Inc.
Dental · 177d
Cleared May 07, 2015
GC KommonBase
K143667
Gc Orthodontics America, Inc.
Dental · 135d
Cleared Mar 18, 2015
DMRC Self-Cure Bracket Adhesive One Step and Primer
K142886
Danville Materials, LLC
Dental · 167d
Cleared Feb 13, 2015
DMRC Dual Cure Orthodontic Band Cement
K142881
Danville Materials, LLC
Dental · 134d
Cleared Feb 04, 2015
DMRC Light Cure Orthodontic Adhesive System
K142880
Daville Materials, LLC
Dental · 125d
Cleared Feb 28, 2013
CLEAR ALIGNER ADHESIVE
K123348
Reliance Orthodontic Products, Inc.
Dental · 120d
Cleared May 21, 2012
ORTHODONTIC FLOWABLE BRACKET ADHESIVE
K120619
Novocol, Inc.
Dental · 82d
Cleared Feb 07, 2012
ORTHO-1(NOT FINALIZED)
K113401
Bisco, Inc.
Dental · 82d
Cleared Feb 02, 2012
APC FLASH-FREE ADHESIVE
K113197
3M Unitek Corporation
Dental · 94d

About Product Code DYH - Regulatory Context

510(k) Submission Activity

194 total 510(k) submissions under product code DYH since 1976, with 194 receiving FDA clearance (average review time: 80 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - DYH Product Code

Recent submissions under DYH have taken an average of 30 days to reach a decision - down from 81 days historically, suggesting improved FDA processing for this classification.

DYH devices are reviewed by the Dental panel. Browse all Dental devices →