The following data is part of a premarket notification filed by Dentalez Group with the FDA for Lube Free Autochuck Turbine With Vortex Air Seal For Use With Star Dental 430 Series Lube Free High Speed Dental Handpie.
| Device ID | K982593 |
| 510k Number | K982593 |
| Device Name: | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Keith C Peithman |
| Correspondent | Keith C Peithman DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-24 |
| Decision Date | 1998-10-22 |
| Summary: | summary |