The following data is part of a premarket notification filed by Dental Imagineers, Llc. with the FDA for Sleepbite.
| Device ID | K013808 |
| 510k Number | K013808 |
| Device Name: | SLEEPBITE |
| Classification | Device, Anti-snoring |
| Applicant | DENTAL IMAGINEERS, LLC. 804 WEST PARK AVE. Ocean, NJ 07712 |
| Contact | William A Belfer |
| Correspondent | William A Belfer DENTAL IMAGINEERS, LLC. 804 WEST PARK AVE. Ocean, NJ 07712 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-15 |
| Decision Date | 2002-01-30 |
| Summary: | summary |