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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K261295
Device Name MultiNeO Dental Implant System
Applicant
Alpha Bio Tec , Ltd.
21 Hareches Blvd., Pob 264
Modi'In,  IL 7171102
Applicant Contact Shani Aroch
Correspondent
Alpha Bio Tec , Ltd.
21 Hareches Blvd., Pob 264
Modi'In,  IL 7171102
Correspondent Contact Shani Aroch
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/20/2026
Decision Date 10/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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