Medical Device Manufacturer · US , Lancaster , PA

Dentalez Group - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1988

Recent clearances: STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS, LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dentalez Group Dental ✕

12 devices

1-12 of 12

Cleared Apr 29, 2003

SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE...

Cleared May 28, 1999

STARDENTAL AXCS STERILE WATER SYSTEM

Cleared Jan 08, 1999

STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS

Cleared Oct 22, 1998

LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430...

Cleared Mar 28, 1996

STAR TITAN SERIES MOTORS & ATTACHMENTS

Cleared Mar 28, 1996

STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES

Cleared Mar 28, 1996

STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE

Cleared Mar 10, 1994

E 4000 DENTAL OPERATING CHAIR

Cleared Jan 21, 1994

QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE

Cleared Aug 29, 1990

HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE

Cleared Feb 02, 1990

HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE

Cleared Apr 21, 1988

ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW