DYH · Class II · 21 CFR 872.3750

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

Leading manufacturers include Dentsply Intl., American Orthodontics and Voco GmbH.

193
Total
193
Cleared
80d
Avg days
1976
Since
Stable submission activity - 3 submissions in the last 2 years
Review times improving: avg 1d recently vs 81d historically

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

193 devices
1–24 of 193
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 Apr 06, 2005
LC BRACKET ADHESIVE SYSTEM
K050750
Dentsply Intl.
Dental · 14d
Cleared Apr 02, 2004
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375
Dentsply Intl.
Dental · 45d
Cleared Feb 06, 2004
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703
Dentsply Intl.
Dental · 73d
Cleared Nov 07, 1985
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523
Dentsply Intl.
Dental · 77d
Cleared Sep 01, 1983
SOLO-TACH
K832292
Dentsply Intl.
Dental · 50d
Cleared Aug 31, 1983
AUTO-TACH
K832291
Dentsply Intl.
Dental · 49d
Cleared Jan 26, 1983
TOOTH CONDITIONER
K823928
Dentsply Intl.
Dental · 28d
Cleared Jan 17, 1978
ORTHODONTIC. PLASTIC BRACKET PRIMER
K780028
3M Company
Dental · 11d

About Product Code DYH - Regulatory Context

510(k) Submission Activity

193 total 510(k) submissions under product code DYH since 1976, with 193 receiving FDA clearance (average review time: 80 days).

Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - DYH Product Code

Recent submissions under DYH have taken an average of 1 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 →