Wire, Orthodontic
Dental · 21 CFR 872.5410
Recent MDR events
328 adverse event reports on file
- PREF ARCH NI-TI LOWER .016 LARGEJul 29, 2026InjurySds De Mexico2016150-2026-00005
- DAMON CUNITI W/STOPS .014X.025 PK 10Jul 1, 2026InjurySds De Mexico2016150-2026-00003
- DENTAL BURRApr 30, 2025MalfunctionDentsply Sirona IncMW5169652
- DAMON CUNITI W/STOPS .014X.025 PK10Dec 4, 2024InjurySds De Mexico2016150-2024-00010
- INBRACE TEETH STRAIGHTENING SYSTEMFeb 20, 2023InjurySwift Health Systems. Inc.3023370823-2023-00002
- INBRACE TOOTH STRAIGHTENING SYSTEM (GEN 2.0)Jan 29, 2023InjurySwift Health Systems, Inc.3023370823-2023-00001
- INBRACE TEETH STRAIGTHENING SYSTEM ( GEN 2.0)Nov 8, 2022InjurySwift Health Systems, Inc.3013023655-2022-00002
- BRIUS BRAVA SYSTEMOct 7, 2022InjuryBrius Technologies3014680924-2022-00004
- LIGATURE CUTTER L:125MMSep 20, 2022InjuryAesculap Ag9610612-2022-00277
- BRIUSMay 18, 2022InjuryBrius3014680924-2022-00003
Event type breakdown
Recalls
4 recall events for this product code
- Ormco/SybronendoTerminatedNov 30, 2015
Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.
Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.
Z-0343-2016 · View FDA record ↗ - Highland Metals, Inc.TerminatedFeb 3, 2014
SuperElastic Regular force NiTi lower or upper Natural arches.
Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.
Z-0922-2014 · View FDA record ↗ - Highland Metals, Inc.TerminatedFeb 3, 2014
SuperElastic Regular force NiTi lower or upper Natural arches.
Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark. Product labeled ad "Lower" may contain "Upper" archwires with a black midline mark.
Z-0923-2014 · View FDA record ↗ - Ormco CorporationTerminatedJan 11, 2012
TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic
The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007.
Z-0639-2012 · View FDA record ↗
Registered firms
179 firms currently registered for this product code
Univy Technology Advanced Co. Ltd
Shanghai, CN
Orthodontic Manufacturer Sia Srl
ROCCA D EVANDRO Caserta, IT
Ortho Pro Dent Llc
Sarasota, FL, US
Dany Bmt Co., Ltd.
Anyang-si Gyeonggi, KR
Kreidler Medizintechnik Gmbh
Wurmlingen Baden-Wurttemberg, DE
Modern Arch Llc
Wyomissing, PA, US
Matrix Health, Inc.
Greenville, SC, US
Ultimate Wireforms, Inc.
Bristol, CT, US
Jin Hsiang Ent Co. Ltd
Changhua, TW
Osstem Orthodontics Inc.
Uiwang-si Gyeonggi, KR
Hangzhou Westlake Biomaterial Co., Ltd.
Hangzhou Zhejiang, CN
Allesee Orthodontic Appliances, Inc.
Sturtevant, WI, US
Hansfive (hangzhou) Dental Technology Co.,ltd
Hangzhou city Zhejiang, CN
Five Star Orthodontic Laboratory & Supply, Inc.
Denton, TX, US
Ec Certification Service Gmbh
St. Veit/Glan Karnten, AT
Specialty Appliances, Llc
CUMMING, GA, US
Ormex S. De R.l. De C.v.
YUCATAN UMAN, MX
Zhejiang Headway Medical Equipment Co., Ltd.
Hangzhou City Zhejiang, CN
Surgipros Llc
Palmetto, FL, US
Dentsply Sirona Orthodontics Inc.
RICHARDSON, TX, US
Guangzhou Cheer-u Material Technology Co., Ltd
Guangzhou Guangdong, CN
O&s Dental, Inc.
Chicago, IL, US
American Orthodontics
SHEBOYGAN, WI, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Sterigenics U.s., Llc
Corona, CA, US
510(k) clearances
30 clearances for this product code
- Ormco Corp.Nov 16, 2011
K112640 · HYPERELASTIC WIRE
- Jay H. GellerOct 5, 1994
K943334 · HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT
- Highland MetalsMay 18, 1994
K935638 · NITINOL, NITI
- Dentauraum, Inc.Feb 4, 1994
K935140 · DENTAURUM STEEL LIGATURE WIRES
- Dentauraum, Inc.Jan 31, 1994
K935142 · DENTAURUM WIRES
- FlexmedicsJan 21, 1994
K934265 · FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE
- Highland MetalsNov 19, 1993
K933374 · NITI COIL SPRINGS
- Highland MetalsNov 16, 1993
K933377 · STAINLESS STEEL ARCHES REPACKER RELABETER