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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 K010185
Device Name 6.0 X 5.7MM DENTAL IMPLANT
Applicant
Bicon, Inc.
123 Morton St., 2nd Floor
Boston,  MA  02130
Applicant Contact VINCENT J MORGAN
Correspondent
Bicon, Inc.
123 Morton St., 2nd Floor
Boston,  MA  02130
Correspondent Contact VINCENT J MORGAN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/19/2001
Decision Date 12/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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