K922984 is an FDA 510(k) clearance for the ORTHODONTIC BITE. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on March 31, 1993, 282 days after receiving the submission on June 22, 1992.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K922984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1992 |
| Decision Date | March 31, 1993 |
| Days to Decision | 282 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | LRK — Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |