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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 K062044
Device Name THE 5.0 X 6.0MM DENTAL IMPLANT
Applicant
Bicon, Inc.
501 Arborway
Boston,  MA  02130
Applicant Contact VINCENT J MORGAN
Correspondent
Bicon, Inc.
501 Arborway
Boston,  MA  02130
Correspondent Contact VINCENT J MORGAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/19/2006
Decision Date 11/21/2006
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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