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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K233616
Device Name Clevaligner Software (V1.0.0)
Applicant
Clevaligner Ltd
King George St 20
Jerusalem,  IL 9426208
Applicant Contact Jonathan Tabet
Correspondent
RS NESS
Hamelacha street 45
Netanya,  IL 4250574
Correspondent Contact Ora Msika
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received11/13/2023
Decision Date 01/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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