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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K922649
Device Name ACE BASIC DENTAL IMPLANT PACK II
Applicant
Ace Surgical Supply Co., Inc.
1034 Pearl St.
P.O. Box 1710
Brockton,  MA  02403
Applicant Contact JOAO R QUINTINO
Correspondent
Ace Surgical Supply Co., Inc.
1034 Pearl St.
P.O. Box 1710
Brockton,  MA  02403
Correspondent Contact JOAO R QUINTINO
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/03/1992
Decision Date 01/10/1994
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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