K213297 is an FDA 510(k) clearance for the Redline. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Johns Dental Laboratories (Terre Haute, US). The FDA issued a Cleared decision on February 9, 2022, 131 days after receiving the submission on October 1, 2021.
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 | K213297 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2021 |
| Decision Date | February 09, 2022 |
| Days to Decision | 131 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. |