510(k) K864474

DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC by Planmeca USA, Inc. — Product Code EHD

K864474 is an FDA 510(k) premarket notification submitted by Planmeca USA, Inc. for the device "DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC". The FDA issued a decision of Substantially Equivalent on November 26, 1986. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Planmeca USA, Inc. has at least 10 other 510(k) clearances on record.