K121396 is an FDA 510(k) clearance for the DYNAFLEX. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Dyna Flex (St. Ann, US). The FDA issued a Cleared decision on August 14, 2012, 97 days after receiving the submission on May 9, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470. The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion..
| 510(k) Number | K121396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2012 |
| Decision Date | August 14, 2012 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NXC — Aligner, Sequential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5470 |
| Definition | The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion. |