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510(k) K253282

ZSmile System by Dror Orthodesign , Ltd. — Product Code NXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2026
Date Received
September 29, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aligner, Sequential
Device Class
Class II
Regulation Number
872.5470
Review Panel
DE
Submission Type

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

Other clearances by Dror Orthodesign , Ltd.

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