The following data is part of a premarket notification filed by Advanced Facialdontics Llc with the FDA for The Nightblocks Appliance.
| Device ID | K192581 |
| 510k Number | K192581 |
| Device Name: | The NightBlocks Appliance |
| Classification | Device, Jaw Repositioning |
| Applicant | Advanced Facialdontics LLC 325 Lake Ave. Unit 759 St James, NY 11780 |
| Contact | Scott Simonetti |
| Correspondent | Scott Simonetti Advanced Facialdontics LLC 325 Lake Ave. Unit 759 St James, NY 11780 |
| Product Code | LQZ |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-19 |
| Decision Date | 2020-01-28 |
| Summary: | summary |