The following data is part of a premarket notification filed by Dentalez Group with the FDA for High Speed Non-fiber Optic Swivel Handpiece.
| Device ID | K902402 |
| 510k Number | K902402 |
| Device Name: | HIGH SPEED NON-FIBER OPTIC SWIVEL HANDPIECE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENTALEZ GROUP 1818 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Gary Foss |
| Correspondent | Gary Foss DENTALEZ GROUP 1818 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-31 |
| Decision Date | 1990-08-29 |