Dentalez, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece, Concentrix MX-AC High-Speed Handpiece
7
Total
7
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dentalez, Inc. Dental ✕
7 devices
Cleared
Jan 06, 2020
SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed...
Dental
124d
Cleared
Mar 28, 2018
Concentrix MX-AC High-Speed Handpiece
Dental
140d
Cleared
Jan 19, 2017
Titan 3 Low Speed Angle Attachments
Dental
146d
Cleared
Apr 08, 2016
430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece,...
Dental
135d
Cleared
Jan 23, 2012
CONCENPIECE,HIGH-SPEED HANDPIECE SERIES
Dental
76d
Cleared
Dec 28, 2009
STARCARE HANDPIECE MAINTENANCE UNIT
Dental
89d
Cleared
Jun 15, 2007
PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422
Dental
78d