510(k) K143117

Wire Sterilization Package with Indicators by American Orthodontics — Product Code FRG

K143117 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "Wire Sterilization Package with Indicators". The FDA issued a decision of Substantially Equivalent on October 29, 2015. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. American Orthodontics has at least 10 other 510(k) clearances on record.