510(k) K972249

ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD by Pelton & Crane Co. — Product Code EHD

K972249 is an FDA 510(k) premarket notification submitted by Pelton & Crane Co. for the device "ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD". The FDA issued a decision of Substantially Equivalent on September 12, 1997. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Pelton & Crane Co. has at least 10 other 510(k) clearances on record.