The following data is part of a premarket notification filed by Dentalez Group with the FDA for Stardental Titan 3 Lubefree Motor Attachments.
| Device ID | K983574 |
| 510k Number | K983574 |
| Device Name: | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | William Guscott |
| Correspondent | William Guscott DENTALEZ GROUP 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1999-01-08 |
| Summary: | summary |