510(k) K173465

Concentrix MX-AC High-Speed Handpiece by Dentalez, Inc. — Product Code EFB

K173465 is an FDA 510(k) premarket notification submitted by Dentalez, Inc. for the device "Concentrix MX-AC High-Speed Handpiece". The FDA issued a decision of Substantially Equivalent on March 28, 2018. 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.