K240597 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 March 5, 2024, 1 day after receiving the submission on March 4, 2024.
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 | K240597 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2024 |
| Decision Date | March 05, 2024 |
| Days to Decision | 1 days |
| Submission Type | Special |
| 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. |