Cleared Special

ZSmile System

K253282 · Dror Orthodesign , Ltd. · Dental
Feb 2026
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K253282 is an FDA 510(k) clearance for the ZSmile System, 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 review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K253282 FDA.gov
FDA Decision Cleared 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

Device Classification

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.