510(k) K926578

UNI-STICK PLASTIC LIGATURE, MODIFIED by American Orthodontics — Product Code ECI

K926578 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "UNI-STICK PLASTIC LIGATURE, MODIFIED". The FDA issued a decision of Substantially Equivalent on March 31, 1993. The device falls under product code ECI (Band, Elastic, Orthodontic), a Class I device regulated under 21 CFR 872.5410. American Orthodontics has at least 10 other 510(k) clearances on record.