510(k) K021378

PORTABLE HDX INTRAORAL X-RAY by Dentalez Group — Product Code EHD

K021378 is an FDA 510(k) premarket notification submitted by Dentalez Group for the device "PORTABLE HDX INTRAORAL X-RAY". The FDA issued a decision of Substantially Equivalent on June 7, 2002. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Dentalez Group has at least 10 other 510(k) clearances on record.