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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K101849
Device Name BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT
Applicant
Bicon, LLC
501 Arborway
Boston,  MA  02130
Applicant Contact VINCENT MORGAN, D.M.D.
Correspondent
Bicon, LLC
501 Arborway
Boston,  MA  02130
Correspondent Contact VINCENT MORGAN, D.M.D.
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/01/2010
Decision Date 10/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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