K253282 is an FDA 510(k) clearance for the ZSmile System. This device is classified as a Aligner, Sequential (Class II - Special Controls, product code NXC).
Submitted by Dror Orthodesign , Ltd. (Jerusalem, IL). The FDA issued a Cleared decision on February 3, 2026, 127 days after receiving the submission on September 29, 2025.
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 | K253282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2025 |
| Decision Date | February 03, 2026 |
| Days to Decision | 127 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. |