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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 K122240
Device Name BONE PLUS BCP EAGLE EYE
Applicant
MEGAGEN IMPLANT CO., LTD
325 N PUENTE ST. UNIT B
BREA,  CA  92821
Applicant Contact APRIL LEE
Correspondent
MEGAGEN IMPLANT CO., LTD
325 N PUENTE ST. UNIT B
BREA,  CA  92821
Correspondent Contact APRIL LEE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received07/27/2012
Decision Date 08/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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