510(k) K950030

HELIODENT MD by Pelton & Crane Co. — Product Code EAP

K950030 is an FDA 510(k) premarket notification submitted by Pelton & Crane Co. for the device "HELIODENT MD". The FDA issued a decision of Substantially Equivalent on February 3, 1995. The device falls under product code EAP (Unit, X-Ray, Intraoral), a Class II device regulated under 21 CFR 872.1810. Pelton & Crane Co. has at least 10 other 510(k) clearances on record.