K191320 is an FDA 510(k) clearance for the Slow Wave DS8. This device is classified as a Device, Jaw Repositioning (Class II - Special Controls, product code LQZ).
Submitted by Slow Wave, Inc. (Spicewood, US). The FDA issued a Cleared decision on October 2, 2020, 506 days after receiving the submission on May 15, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K191320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2019 |
| Decision Date | October 02, 2020 |
| Days to Decision | 506 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 |