Dentalez Group
Lancaster, PA, US
Dentalez Group appears in FDA device records in Lancaster, PA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Dentalez Group between 1988 and 2003. The busiest year on record is 1996, with 3. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1990 | 2 |
| 1994 | 2 |
| 1996 | 3 |
| 1998 | 1 |
| 1999 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K030133 | SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE | EBF | Substantially Equivalent | |
| K021378 | PORTABLE HDX INTRAORAL X-RAY | EHD | Substantially Equivalent | |
| K990844 | STARDENTAL AXCS STERILE WATER SYSTEM | EIA | Substantially Equivalent | |
| K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | EGS | Substantially Equivalent | |
| K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE | EFB | Substantially Equivalent | |
| K960719 | STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE | EFA | Substantially Equivalent | |
| K960507 | STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES | EFA | Substantially Equivalent | |
| K960260 | STAR TITAN SERIES MOTORS & ATTACHMENTS | EFA | Substantially Equivalent | |
| K925567 | E 4000 DENTAL OPERATING CHAIR | KLC | Substantially Equivalent | |
| K931093 | QUICK-CONNECT 360 SWIVEL TIP AUTOCLAVABLE SYRINGE | EIA | Substantially Equivalent | |
| K902402 | HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE | EBF | Substantially Equivalent | |
| K896361 | HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE | EFB | Substantially Equivalent | |
| K881253 | ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW | ELC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain