510(k) K891354

ORTHODONTIC COTTON ROLL HOLDERS by American Orthodontics — Product Code KHR

K891354 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "ORTHODONTIC COTTON ROLL HOLDERS". The FDA issued a decision of Substantially Equivalent on April 17, 1989. The device falls under product code KHR (Absorber, Saliva, Paper), a Class I device regulated under 21 CFR 872.6050. American Orthodontics has at least 10 other 510(k) clearances on record.