510(k) K960028

ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM by Dentsply Intl. — Product Code EAP

K960028 is an FDA 510(k) premarket notification submitted by Dentsply Intl. for the device "ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 1, 1996. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Dentsply Intl. has at least 10 other 510(k) clearances on record.