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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 K153676
Device Name OSTEON III
Applicant
Genoss Co., Ltd.
1f Gyeonggi R&Db Center, 105 Gwanggyo-Ro, Yeongtong-Gu
Suwon-Si,  KR 433-270
Applicant Contact EUNSANG LEE
Correspondent
Genoss Co., Ltd.
1f Gyeonggi R&Db Center, 105 Gwanggyo-Ro, Yeongtong-Gu
Suwon-Si,  KR 433-270
Correspondent Contact EUNSANG LEE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received12/21/2015
Decision Date 09/14/2016
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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