510(k) K895714

ORTHO-KEV APPLIANCE REINFORCING SYSTEM by American Orthodontics — Product Code EBI

K895714 is an FDA 510(k) premarket notification submitted by American Orthodontics for the device "ORTHO-KEV APPLIANCE REINFORCING SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 1989. The device falls under product code EBI (Resin, Denture, Relining, Repairing, Rebasing), a Class II device regulated under 21 CFR 872.3760. American Orthodontics has at least 10 other 510(k) clearances on record.