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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, Animal Source
510(k) Number K150079
Device Name Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
Applicant
Nibec Co., Ltd.
Iwol Electricity-Electronic Agro-Industrial Complex, 1127,
Sinwo-Ri, Iwol-Myeon
Jincheon-Gun,  KR 365-824
Applicant Contact YOON-JEONG PARK
Correspondent
Smile US
22395 S Western Ave., Suite 304
Torrance,  CA  90501
Correspondent Contact TAKASHI YAMADA
Regulation Number872.3930
Classification Product Code
NPM  
Date Received01/15/2015
Decision Date 12/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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