ZSmile System— 510(k) K253282
Substantially EquivalentDror Orthodesign , Ltd.
FDA 510(k) clearance K253282 for ZSmile System, Substantially Equivalent on 2026-02-03. Applicant: Dror Orthodesign , Ltd.. Device class: 2.
Summary
Dror Orthodesign's ZSmile System is filed under product code NXC, sequential aligner. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 872.5470. Dental is both the classification panel and the review panel, and it came in as a Special 510(k).
Dror Orthodesign filed from Jerusalem, Israel. The decision came 127 calendar days after FDA received it (September 29, 2025 to February 3, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Dror Orthodesign , Ltd.
- Product code
- Product code NXC
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Jerusalem, IL
Recent devices under product code NXC
view allAdverse events under product code NXC
product code NXC- Injury
- 15,206
- Malfunction
- 2,576
- Other
- 9
- Total
- 17,791
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.