Tube, Orthodontic
Dental · 21 CFR 872.5410
Recent MDR events
25 adverse event reports on file
- 3M¿ VICTORY SERIES¿ BUCCAL TUBEJan 14, 2025Injury3m Unitek Corporation2020467-2025-00001
- SNAPLINKNov 13, 2020MalfunctionOrmco Corporation2016150-2020-00005
- BASE RX SGL 022/LR7 -30T -1A 4DJan 10, 2019InjuryDentsply Sirona Orthodontics Inc.2418500-2018-00002
- BASE RX SGL 022/LL7 -30T -1A 4DJan 10, 2019InjuryDentsply Sirona Orthodontics Inc.2418500-2018-00001
- SNAPLINK BUCCAL TUBEAug 19, 2013InjuryOrmco Corporation2016150-2013-00099
- SNAPLINK BUCCAL TUBEAug 14, 2013InjuryOrmco Corporation2016150-2013-00077
- SNAPLINK BUCCAL TUBEAug 14, 2013InjuryOrmco Corporation2016150-2013-00078
- SNAPLINK BUCCAL TUBEAug 14, 2013InjuryOrmco Corporation2016150-2013-00079
- SNAPLINK BUCCAL TUBEAug 14, 2013InjuryOrmco Corporation2016150-2013-00080
- SNAPLINK BUCCAL TUBEAug 14, 2013InjuryOrmco Corporation2016150-2013-00081
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Ormco/SybronendoTerminatedFeb 6, 2020
SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.
Z-1257-2020 · View FDA record ↗ - Ormco/SybronendoTerminatedFeb 6, 2020
SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.
Z-1258-2020 · View FDA record ↗ - Ormco/SybronendoTerminatedApr 10, 2013
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0
Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival (0) offset brackets, but actually contains distal (10) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in
Z-1084-2013 · View FDA record ↗ - Ortho Organizers IncTerminatedFeb 15, 2011
ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each);
Products were mis-labeled as nickel free.
Z-1246-2011 · View FDA record ↗
Registered firms
113 firms currently registered for this product code
Ze Fang Technology Co., Ltd.
Taichung, TW
Wuhu Guli Ortho Co.,ltd
Wuhu Anhui, CN
Patterson Dental Supply, Inc.
ST. PAUL, MN, US
D B Orthodontics Ltd
WEST YORKSHIRE England, GB
Zain's Medical Image
SIALKOT Punjab, PK
Funing Meitedental Factory
Yancheng Jiangsu, CN
Myofunctional Research Co. Usa
Rancho Cucamonga, CA, US
Xplora Usa Llc
Carrollton, TX, US
E. Tec Sa De C.v.
Tijuana Baja California, MX
World Class Technology Corporation
MCMINNVILLE, OR, US
Hangzhou Dtc Medical Apparatus Co., Ltd
Hangzhou Zhejiang, CN
Wuxi Lyusmile Imp And Exp Co.,ltd
WUXI Jiangsu, CN
Ricomed Manufacturing
Richardson, TX, US
Zhejiang Yamei Medical Equipment Technology Co., Ltd.
Yang Jiao Lang Zin'an Town Zhejiang, CN
Hangzhou Westlake Biomaterial Co., Ltd.
Hangzhou Zhejiang, CN
Jinhua Glamb Medical Equipment Co.,ltd
Jinhua City Zhejiang, CN
Jmu Dental, Inc
Fullerton, CA, US
Gni Co., Ltd
Hwaseong-si Gyeonggi, KR
Sharp Detail Orthodontic Laboratory S De El De Cv
Tijuana Baja California, MX
Summit Orthodontic Services, Inc.
Schaumburg, IL, US
Hansfive (hangzhou) Dental Technology Co.,ltd
Hangzhou city Zhejiang, CN
Zhejiang Shinye Medical Technology Corp.,ltd
HANGZHOU Zhejiang, CN
Orthodentalusa Corp.
Weston, FL, US
Ortotec De Bc Mx Sa De Cv
Tecate Baja California, MX
Henan Baistra Medical Devices Limited
Zhengzhou Henan, CN
510(k) clearances
8 clearances for this product code
- Jon-Ko Products, Inc.May 23, 1995
K943421 · ORTHODONITC ELASTOMERIC SLEEVING
- Ortho SpecialtiesFeb 2, 1994
K936243 · REGENCY TUBE
- Dentauraum, Inc.Jan 31, 1994
K935143 · DENTAURUM STAINLESS STEEL TUBING
- Aequitron Medical, Inc.Sep 19, 1991
K911399 · NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)
- Percussionaire Corp.Jan 9, 1990
K896586 · RATE INCREASE FOR IPPB/IPV
- Alexotek Co.Apr 5, 1984
K834446 · ALEXOTEK LINGUAL TUBES
- Alexotek Co.Feb 28, 1984
K834392 · LABIAL CUSPID TUBE
- Rocky Mountain Orthodontics, Inc.Feb 16, 1978
K780205 · ORTHODONTIC BUCCAL TUBE