Bracket, Plastic, Orthodontic
Dental · 21 CFR 872.5470
Recent MDR events
45 adverse event reports on file
- RETAINER/BRACKETApr 27, 2026InjuryDuo OrthodonticsMW5187309
- INVISALIGNDec 6, 2017InjuryAlign TechnologiesMW5073817
- INSIGNIAJun 24, 2015MalfunctionOrmco Corporation2016150-2015-00019
- INSIGNIAJun 17, 2015InjuryOrmco Corporation2016150-2015-00018
- INSIGNIAMar 12, 2015InjuryOrmco Corportation2016150-2015-00013
- INSIGNIAJan 28, 2015InjuryOrmco Corportation2016150-2015-00003
- INSIGNIAApr 7, 2014InjuryOrmco Corportation2016150-2014-00024
- INSIGNIAApr 7, 2014InjuryOrmco Corportation2016150-2014-00025
- SPIRIT MBMar 14, 2014MalfunctionOrmco Corporation2016150-2014-00023
- DAMON QJan 7, 2014InjuryOrmco Corporation2016150-2014-00002
Event type breakdown
Recalls
5 recall events for this product code
- Ormco/SybronendoTerminatedApr 4, 2014
Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013.
Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction.
Z-1330-2014 · View FDA record ↗ - Ormco CorporationTerminatedNov 16, 2011
Spirit MB Brackets, part #494-1210.
Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
Z-0200-2012 · View FDA record ↗ - Ormco CorporationTerminatedNov 16, 2011
Spirit MB Brackets, part #494-1211.
Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error.
Z-0201-2012 · View FDA record ↗ - Ormco CorporationTerminatedNov 26, 2005
Damon 3 Bracket
Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
Z-0203-06 · View FDA record ↗ - Ormco CorporationTerminatedNov 26, 2005
Damon 3 Bracket
Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance.
Z-0204-06 · View FDA record ↗
Registered firms
44 firms currently registered for this product code
Ec Certification Service Gmbh
St. Veit/Glan Karnten, AT
Ormco Corporation
Pomona, CA, US
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Ormco Corporation
Brea, CA, US
Great Lakes Dental Technologies, Ltd.
TONAWANDA, NY, US
Xplora Usa Llc
Carrollton, TX, US
Dentaurum Gmbh & Co. Kg
ISPRINGEN Baden-Wurttemberg, DE
Sawbros Industries Pvt Ltd
NOIDA Uttar Pradesh, IN
Mainline Medical Dental Supply
North York Ontario, CA
Solventum Orthodontics Corporation
Monrovia, CA, US
Gestenco International Ab
GOTEBORG Vastra Gotaland, SE
Ortho Organizers, Inc.
Savannah, GA, US
Modern Orthodontics
LUDHIANA, PUNJAB, IN
Solventum Us Llc
Irvine, CA, US
Rmo
Franklin, IN, US
Ortho Arch Company Inc
Schaumburg, IL, US
Stick Tech Ltd.
TURKU Pirkanmaa, FI
510(k) clearances
42 clearances for this product code
- Ortho Organizers, Inc.Nov 27, 2025
K252760 · Carriere® Motion Pro® Clear Bite Corrector
- Ec Certification Service GmbHApr 21, 2025
K251196 · Composite Orthodontic Brackets and Buttons
- Braces on Demand, Inc.Dec 3, 2020
K201940 · Braces on Demand Bracket
- Blue Sky BioNov 9, 2018
K182338 · Blue Sky Bio Computerized Orthodontic Bracket System
- Tomy, Inc.Oct 30, 2018
K180718 · ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
- Ortho Organizers, Inc.Nov 28, 2016
K160720 · Carriere Motion Clear Class II
- OracrewAug 26, 2016
K150830 · CompleClear Plastic Orthodontic Bracket and Wire Appliance
- Great Lakes Orthodontics, Ltd.Mar 24, 2016
K150702 · Exceed Tx