510(k) K062529

BELMAX CM MODEL X168 by Takara Belmont USA, Inc. — Product Code MUH

K062529 is an FDA 510(k) premarket notification submitted by Takara Belmont USA, Inc. for the device "BELMAX CM MODEL X168". The FDA issued a decision of Substantially Equivalent on October 5, 2006. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Takara Belmont USA, Inc. has at least 5 other 510(k) clearances on record.