510(k) K153411

430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece by Dentalez, Inc. — Product Code EFB

K153411 is an FDA 510(k) premarket notification submitted by Dentalez, Inc. for the device "430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece". The FDA issued a decision of Substantially Equivalent on April 8, 2016. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Dentalez, Inc. has at least 6 other 510(k) clearances on record.