13 results
·
68ms
·
Sources: EU EUDAMED, US FDA
ORTHODONTIC BUCCAL TUBE
FDA 510(k)
FDA Class 1
·Dental
meitedental
FDA UDI
Funing Meitedental Factory·06979861312512·egdewise /roth /mbt buccal tube,single/double/t...
QUICK-FIT MOLAR BAND ASSEMBLIES
FDA Adverse Event
Other
·ORTHO TECHNOLOGY, INC·Product code ECM·May 24, 2012
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
FDA Enforcement
Class II
·Terminated·Ormco/Sybronendo·April 17, 2013
ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each); ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB UL 6 Convertible .018-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-418, NF DB UL/LR 6&7 Mini Single .022 0T 0O; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-427, NF DB UR 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Label ID Reference Number 351-428, NF DB UL 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-459, NF DB LR 6 Convertible .022-25T 4DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-460, NF DB LL 6 Convertible .022-25T 4DO HK-Each.
FDA Recall
Terminated
·Ortho Organizers Inc·Product code DZD·November 1, 2010
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment
FDA Recall
Terminated
·Ormco/Sybronendo·Product code DZD·March 8, 2013
Orthodontic Buccal Tubes
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Ningbo Denrotary Medical Apparatus Co., Ltd.·1 device
Orthodontic Buccal Tubes
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·ASTAR ORTHODONTICS INC.·357 devices
Orthodontic Buccal Tubes
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·ASTAR ORTHODONTICS INC.·72 devices
Orthodontic Buccal Tubes
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Zhejiang Protect Medical Equipment Co.,Ltd.·1 device
APC PLUS, CLARITY, MINI UNI-TWIN, VICTORY SERIES
FDA Adverse Event
Injury
·3M UNITEK·Product code DYH·May 9, 2012
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
FDA Recall
Terminated
·Ormco/Sybronendo·Product code DZD·January 17, 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
FDA Recall
Terminated
·Ormco/Sybronendo·Product code DZD·January 17, 2020