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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 K102981
Device Name ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM
Applicant
Ace Surgical Supply Company, Inc.
1034 Pearl St.
Brockton,  MA  02401
Applicant Contact CAROL A HOUTS
Correspondent
Ace Surgical Supply Company, Inc.
1034 Pearl St.
Brockton,  MA  02401
Correspondent Contact CAROL A HOUTS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/07/2010
Decision Date 12/20/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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