5 results
·
38ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
Heat Activated Niti Arches, Natural, Upper, .019x 25", Arch Wires. Packaged in 19 packages of 100 and 6 packages of 10. Highland Metals, Inc. Wire used for orthodontic treatment to place in the brackets to shape teeth.
FDA Recall
Terminated
·Highland Metals·Product code D·July 12, 2011
SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
FDA Enforcement
Class II
·Terminated·Highland Metals, Inc.·February 12, 2014
SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
FDA Enforcement
Class II
·Terminated·Highland Metals, Inc.·February 12, 2014
SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
FDA Recall
Terminated
·Highland Metals, Inc.·Product code DZC·December 13, 2013
SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10 or 100 count packages. Highland Metals Inc. San Jose, CA The devices are intended to provide force to the teeth to effect movement in order to alter their position.
FDA Recall
Terminated
·Highland Metals, Inc.·Product code DZC·December 13, 2013