K223355 is an FDA 510(k) clearance for the Tera Harz Clear. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Graphy, Inc. (Seoul, KR). The FDA issued a Cleared decision on November 3, 2022, 1 day after receiving the submission on November 2, 2022.
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 | K223355 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2022 |
| Decision Date | November 03, 2022 |
| Days to Decision | 1 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. |