510(k) K090931

CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR by W&H Dentalwerk Buermoos GmbH — Product Code EKX

K090931 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoos GmbH for the device "CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR". The FDA issued a decision of Substantially Equivalent on December 15, 2009. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. W&H Dentalwerk Buermoos GmbH has at least 10 other 510(k) clearances on record.