DYH · Class II · 21 CFR 872.3750

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

Leading manufacturers include Sybron Dental Specialties, Inc., Ormco Corp. and American Orthodontics.

194
Total
194
Cleared
80d
Avg days
1976
Since
Growing category - 4 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 23d 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 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 Feb 07, 2012
ORTHO-1(NOT FINALIZED)
K113401
Bisco, Inc.
Dental · 82d
Cleared Sep 07, 2011
OPAL BAND CEMENT
K111696
Ultradent Products, Inc.
Dental · 82d
Cleared Apr 29, 2010
OPAL BOND FLOW
K100301
Ultradent Products, Inc.
Dental · 85d
Cleared Mar 23, 2010
OPAL BOND MV
K094006
Ultradent Products, Inc.
Dental · 85d
Cleared Apr 29, 2009
OPAL SEAL
K090355
Ultradent Products, Inc.
Dental · 77d
Cleared Jun 11, 2008
GC OPB-100
K080724
GC America, Inc.
Dental · 89d
Cleared Feb 15, 2008
GC MODELS OPA-100 AND JC-50
K073588
GC America, Inc.
Dental · 57d
Cleared Jul 06, 2006
GRENGLOO
K061481
Ormco Corp.
Dental · 37d
Cleared Apr 06, 2005
LC BRACKET ADHESIVE SYSTEM
K050750
Dentsply Intl.
Dental · 14d
Cleared Nov 15, 2004
D3 CHROMA
K042422
Sybron Dental Specialties, Inc.
Dental · 69d
Cleared Apr 02, 2004
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375
Dentsply Intl.
Dental · 45d

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 increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DYH Product Code

Recent submissions under DYH have taken an average of 23 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 →