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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 K250872
Device Name Bioline Dental Implant System
Applicant
Bioline Dental Implant Systems, Ltd.
1 Haella St. Tefen Industrial Park Pob 70
Migdal Tefen,  IL 2495900
Applicant Contact Asher Ohayon
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030
Correspondent Contact Angela Blackwell
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received03/24/2025
Decision Date 06/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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