510(k) K880982

ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY by Orion Corporation Soredex — Product Code KPR

K880982 is an FDA 510(k) premarket notification submitted by Orion Corporation Soredex for the device "ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY". The FDA issued a decision of Substantially Equivalent on June 6, 1988. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Orion Corporation Soredex has at least 3 other 510(k) clearances on record.