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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K253282
Device Name ZSmile System
Applicant
Dror Orthodesign , Ltd.
3 Shatner St.
Jerusalem,  IL 9546103
Applicant Contact Orly Maor
Correspondent
Dror Orthodesign , Ltd.
3 Shatner St.
Jerusalem,  IL 9546103
Correspondent Contact Orly Maor
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/29/2025
Decision Date 02/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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