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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K253883
Device Name Bonalive Maxillofacial
Applicant
Bonalive , Ltd.
Biolinja 2
Turku,  FI 20750
Applicant Contact Jenna Saarimäki
Correspondent
Obelix Consulting
806 Jefferson St.
Bastrop,  TX  78602
Correspondent Contact Elisa Maldonado-Holmertz
Regulation Number872.3930
Classification Product Code
LYC  
Date Received12/04/2025
Decision Date 05/14/2026
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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