FDA-Device2014-02-12Class II
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.
Highland Metals, Inc.
Hazard
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.
Sold states
Worldwide Distribution - USA including IL, KY, MI, NY, CA, FL, LA and Internationally to Switzerland., Denmark, Greece, Australia, England, and Canada.
Affected count
9 packages of each lot number.
Manufactured in
419 Perrymont Ave, San Jose, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0922-2014Don't want to check this manually?
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