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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K101890
Device Name BALL ABUTMENT SYSTEM
Applicant
MEGAGEN CO., LTD.
325 N. PUENTE STREET
UNIT B
BREA,  CA  92821
Applicant Contact JOYCE BANG
Correspondent
MEGAGEN CO., LTD.
325 N. PUENTE STREET
UNIT B
BREA,  CA  92821
Correspondent Contact JOYCE BANG
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/07/2010
Decision Date 02/03/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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