510(k) K800133

PANOREX II DENTAL X-RAY UNIT by Pennwalt Corp. — Product Code EHD

K800133 is an FDA 510(k) premarket notification submitted by Pennwalt Corp. for the device "PANOREX II DENTAL X-RAY UNIT". The FDA issued a decision of Substantially Equivalent on March 3, 1980. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Pennwalt Corp. has at least 5 other 510(k) clearances on record.