FDA 510(k) Applications Submitted by DENTALEZ, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K173465 11/08/2017 Concentrix MX-AC High-Speed Handpiece DentalEZ, Inc.
K153411 11/25/2015 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece DENTALEZ, INC.
K113301 11/08/2011 CONCENPIECE,HIGH-SPEED HANDPIECE SERIES DENTALEZ, INC.
K093072 09/30/2009 STARCARE HANDPIECE MAINTENANCE UNIT DENTALEZ, INC.
K192412 09/04/2019 SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece DentalEZ, Inc.
K070869 03/29/2007 PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 DENTALEZ, INC.


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