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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 K080074
Device Name ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
Applicant
Ace Surgical Supply Co., Inc.
1034 Pearl St.
Brockton,  MA  02301
Applicant Contact J. EDWARD CARCHIDI
Correspondent
Ace Surgical Supply Co., Inc.
1034 Pearl St.
Brockton,  MA  02301
Correspondent Contact J. EDWARD CARCHIDI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/11/2008
Decision Date 02/14/2008
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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