510(k) Report

Devices descending from K894781

3 later devices reach Optiflex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081143Biomers Translucent Orthodontic WireBiomers Product, LLC20082—
+2K110796Simpliclear Rectangular Orthodontic WireBiomers Products, LLC20111—
+3K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew20160—