Not currently registered with FDA under this name
Dentalez Group
Lancaster, PA, United States. Named as applicant on 13 dental 510(k) clearances between 1988 and 2003. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 131988–2003
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1980–2026
510(k) clearances
Clearances on which FDA names Dentalez Group as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Apr 2003 | K030133 | SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE | EBF Resin Tooth Shade Material |
| 7 Jun 2002 | K021378 | PORTABLE HDX INTRAORAL X-RAY | EHD Extraoral with Timer X-Ray Unit |
| 28 May 1999 | K990844 | STARDENTAL AXCS STERILE WATER SYSTEM | EIA Operative Dental Unit |
| 8 Jan 1999 | K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 22 Oct 1998 | K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE | EFB Dental Air-Powered Handpiece |
| 28 Mar 1996 | K960719 | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE | EFA Dental Belt and/or Gear Driven Handpiece |
| 28 Mar 1996 | K960507 | STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES | EFA Dental Belt and/or Gear Driven Handpiece |
| 28 Mar 1996 | K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS | EFA Dental Belt and/or Gear Driven Handpiece |
| 10 Mar 1994 | K925567 | E 4000 DENTAL OPERATING CHAIR | KLC Dental Chair with Operative Unit |
| 21 Jan 1994 | K931093 | QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE | EIA Operative Dental Unit |
| 29 Aug 1990 | K902402 | HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE | EBF Resin Tooth Shade Material |
| 2 Feb 1990 | K896361 | HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE | EFB Dental Air-Powered Handpiece |
| 21 Apr 1988 | K881253 | ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW | ELC Ultrasonic Scaler |
Some of these clearances are listed with FDA today by another company: Dentalez, Inc. (3).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.