Company ยท US
Dentalez Group
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2003. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 3 |
| EBF | Material, Tooth Shade, Resin | 2 |
| EFB | Handpiece, Air-Powered, Dental | 2 |
| EIA | Unit, Operative Dental | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 |
| ELC | Scaler, Ultrasonic | 1 |
| KLC | Chair, Dental, With Operative Unit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 2003 | K030133 | SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE Dentalez Group | EBF |
| Jun 7, 2002 | K021378 | PORTABLE HDX INTRAORAL X-RAY Dentalez Group | EHD |
| May 28, 1999 | K990844 | STARDENTAL AXCS STERILE WATER SYSTEM Dentalez Group | EIA |
| Jan 8, 1999 | K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS Dentalez Group | EGS |
| Oct 22, 1998 | K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE Dentalez Group | EFB |
| Mar 28, 1996 | K960719 | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE Dentalez Group | EFA |
| Mar 28, 1996 | K960507 | STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES Dentalez Group | EFA |
| Mar 28, 1996 | K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS Dentalez Group | EFA |
| Mar 10, 1994 | K925567 | E 4000 DENTAL OPERATING CHAIR Dentalez Group | KLC |
| Jan 21, 1994 | K931093 | QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE Dentalez Group | EIA |
| Aug 29, 1990 | K902402 | HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE Dentalez Group | EBF |
| Feb 2, 1990 | K896361 | HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE Dentalez Group | EFB |
| Apr 21, 1988 | K881253 | ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW Dentalez Group | ELC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||