510(k) Report

Devices descending from K081143

2 later devices reach Biomers Translucent Orthodontic Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110796Simpliclear Rectangular Orthodontic WireBiomers Products, LLC20111—
+2K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew20160—