Spring, Orthodontic
Dental · 21 CFR 872.5410
Recent MDR events
7 adverse event reports on file
- FORSUS FATIGUE RESISTANCE SPRINGNov 19, 2013Injury3m UnitekMW5033043
- FORSUS FATIGUE RESISTANT DEVICE PUSH ROD XSOct 25, 2011Injury3m Unitek2020467-2011-00003
- FORSUS DIRECT PUSHRODOct 5, 2009Injury3m Unitek2020467-2009-00003
- AFORSUS FATIGUE RESISTANCE DEVICE SPRINT MODELFeb 16, 2009Injury3m Unitek2020467-2009-00001
- FORSUS FATIGUE RESISTANT DEVICE SPRING MODULEMay 12, 2006Injury3m Unitek2020467-2006-00004
- PARALLEL JAW SPRING CLIPJul 13, 2004OtherEdwards Lifesciences6000002-2004-00157
- FORSUS FATIGUE RESISTANT DEVICE WITH DIRECT PUSH RODApr 3, 2002Injury3m Unitek2020467-2002-00002
Event type breakdown
Most-reported manufacturers
Recalls
13 recall events for this product code
- TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arc
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1783-2018 · View FDA record ↗ - TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arc
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1784-2018 · View FDA record ↗ - TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arc
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1785-2018 · View FDA record ↗ - TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arc
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1786-2018 · View FDA record ↗ - TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, ar
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1787-2018 · View FDA record ↗ - TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, ar
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1788-2018 · View FDA record ↗ - TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, ar
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1789-2018 · View FDA record ↗ - TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, ar
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1790-2018 · View FDA record ↗ - TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arc
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1791-2018 · View FDA record ↗ - TP Orthodontics, Inc.TerminatedUnknown
Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for correcting class 2 malocclusions by applying light forces on the teeth using a tube, arc
The firm has received 106 complaints of the device breaking in the patient's mouth. Device breakage may cause injury to the patient.
Z-1792-2018 · View FDA record ↗
Registered firms
81 firms currently registered for this product code
Orthodentalusa Corp.
Weston, FL, US
Solventum Orthodontics Corporation
Monrovia, CA, US
Orthodontic Manufacturer Sia Srl
ROCCA D EVANDRO Caserta, IT
International Orthodontic Services, Pc
Stafford, TX, US
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Xplora Usa Llc
Carrollton, TX, US
Ortompl Sa De Cv
Tecate Baja California, MX
Debo Medical Technology (shijiazhuang) Co., Ltd.
Shijiazhuang Hebei, CN
Guangzhou Oo Medical Scientific Limited
Guangzhou Guangdong, CN
Heilongjiang Rainbow Technology Co., Ltd.
Jiamusi Heilongjiang, CN
Gni Co., Ltd
Hwaseong-si Gyeonggi, KR
Us Orthodontic Products
Norwalk, CA, US
Ortho Solutions Lc
Lake Saint Louis, MO, US
O&s Dental, Inc.
Chicago, IL, US
Improve Co.,limited
Hong Kong Xinjiang, CN
Kerr Corporation
Pomona, CA, US
Acme-monaco Corp.
PRESQUE ISLE, ME, US
Biomaterials Korea Inc.
Hanam-si Gyeonggi, KR
Guangzhou Cheer-u Material Technology Co., Ltd
Guangzhou Guangdong, CN
Gc Orthodontics America Inc.
Alsip, IL, US
Sino Ortho Limited
HANGZHOU Zhejiang, CN
Hangzhou Wise Medical Device Co.,ltd
Hangzhou Zhejiang, CN
First Dental Supplies Llc
Winter Garden, FL, US
Zhejiang Protect Medical Equipment Co. Ltd.
Anji Zhejiang, CN
Midwest Dental
Wichita Falls, TX, US
510(k) clearances
7 clearances for this product code
- Ormco Corp.Aug 17, 1994
K943068 · MAGNEFORCE
- Gac Intl., Inc.Aug 5, 1994
K933542 · MESIAL LOOP BAR
- Orthoplus, Inc.Jul 13, 1994
K942492 · ADJUSTABLE BITE CORRECTOR
- Active Vertical Correctors, Inc.Jan 4, 1985
K844234 · ACTIVE VERTICAL CORRECTOR APPLIANCE
- Medical Magnetics, Inc.Dec 21, 1984
K843550 · ORTHOMAG MAGNETIC FORCE SYSTEM
- Active Vertical Correctors, Inc.Dec 3, 1984
K843344 · ACTIVE VERTICAL CORRECTOR ACTIVE BITE
- Hmw IndustriesApr 5, 1977
K770558 · ISODYNE