510(k) K103689

PLANMECA PROMAX 3D MID by Planmeca Oy — Product Code MUH

K103689 is an FDA 510(k) premarket notification submitted by Planmeca Oy for the device "PLANMECA PROMAX 3D MID". The FDA issued a decision of Substantially Equivalent on March 17, 2011. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Planmeca Oy has at least 10 other 510(k) clearances on record.