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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 K050712
Device Name 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM 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 Received03/17/2005
Decision Date 04/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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