K192581 is an FDA 510(k) clearance for the The NightBlocks Appliance. This device is classified as a Device, Jaw Repositioning (Class II - Special Controls, product code LQZ).
Submitted by Advanced Facialdontics, LLC (St James, US). The FDA issued a Cleared decision on January 28, 2020, 131 days after receiving the submission on September 19, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K192581 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2019 |
| Decision Date | January 28, 2020 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LQZ - Device, Jaw Repositioning |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |