Dentalez Group

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K030133SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENApril 29, 2003
K021378PORTABLE HDX INTRAORAL X-RAYJune 7, 2002
K990844STARDENTAL AXCS STERILE WATER SYSTEMMay 28, 1999
K983574STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTSJanuary 8, 1999
K982593LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH October 22, 1998
K960507STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECESMarch 28, 1996
K960719STAR DENTAL 430 SERIES HIGH SPEED HANDPIECEMarch 28, 1996
K960260STAR TITAN SERIES MOTORS & ATTACHMENTSMarch 28, 1996
K925567E 4000 DENTAL OPERATING CHAIRMarch 10, 1994
K931093QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGEJanuary 21, 1994
K902402HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECEAugust 29, 1990
K896361HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATUREFebruary 2, 1990
K881253ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SWApril 21, 1988