510(k) K891328

PREFORMED TEMPLATE FOR TOOTH POSITIONER by American Orthodontics — Product Code KMY

K891328 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "PREFORMED TEMPLATE FOR TOOTH POSITIONER". The FDA issued a decision of Substantially Equivalent on March 31, 1989. The device falls under product code KMY (Positioner, Tooth, Preformed), a Class I device regulated under 21 CFR 872.5525. American Orthodontics has at least 10 other 510(k) clearances on record.