510(k) K051464

PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) by Planmeca Oy — Product Code EHD

K051464 is an FDA 510(k) premarket notification submitted by Planmeca Oy for the device "PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)". The FDA issued a decision of Substantially Equivalent on June 24, 2005. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Planmeca Oy has at least 10 other 510(k) clearances on record.