510(k) K891327

NICKLE-TITANIUM ORTHODONTIC WIRE by American Orthodontics — Product Code FJF

K891327 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "NICKLE-TITANIUM ORTHODONTIC WIRE". The FDA issued a decision of Substantially Equivalent on May 10, 1989. The device falls under product code FJF (Detector, Air Bubble), a Class II device regulated under 21 CFR 876.5820. American Orthodontics has at least 10 other 510(k) clearances on record.