DYHClass II

Adhesive, Bracket And Tooth Conditioner, Resin

Dental · 21 CFR 872.3750

MDR events37All time

Recalls1All time

Registered firms232Currently listed

510(k) clearances194All time

Recent MDR events

37 adverse event reports on file

ORTHO SOLO¿May 15, 2026
InjurySds De Mexico2016150-2026-00002
ORMCO¿ ETCHFREE BONDINGSep 25, 2025
InjuryOrmco2016150-2025-00004
3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKETDec 11, 2017
Injury3m Unitek Corporaion2020467-2017-00005
3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKETDec 11, 2017
Injury3m Unitek Corporaion2020467-2017-00006
APC FLASH-FREE VICTORY SERIES SUPERIOR FIT BUCCAL TUBENov 22, 2017
Injury3m Unitek Corporaion2020467-2017-00003
ORTHO SOLOJun 19, 2017
InjuryOrmco Corporation2016150-2017-00001
3M UNITEK TRANSBOND TX ADHESIVEJun 13, 2017
Injury3m Unitek Corporaion2020467-2017-00002
3M ESPE RELYX LUTING PLUS CEMENT AUTOMIX PASTE A+ BAug 22, 2016
Injury3m DentalMW5064315
UNITEK(TM) MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENTOct 28, 2015
Injury3m Unitek Corporation2020467-2015-00001
NEOBAND LIGHT CURE BAND CEMENTJul 29, 2015
InjuryGac International2418500-2015-00002

Event type breakdown

Injury30

Other4

Malfunction2

Death1

Most-reported manufacturers

3m Unitek14 Ormco Corporation5 3m Unitek Corporaion4 Ultradent Products, Inc.2 Unspecified1 3-m1 3m1 3m Dental1

Recalls

1 recall events for this product code

Ormco Corporation
TerminatedApr 10, 2008
Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740
Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.
Z-0916-2008 · View FDA record ↗

Registered firms

232 firms currently registered for this product code

510(k) clearances

194 clearances for this product code