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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 K070905
Device Name ENDOSSEOUS DENTAL IMPLANT SYSTEM
Applicant
SOUTHERN IMPLANTS, INC.
10355 B DEMOCRACY LANE
FAIRFAX,  VA  22030
Applicant Contact GRETA M HOLS
Correspondent
SOUTHERN IMPLANTS, INC.
10355 B DEMOCRACY LANE
FAIRFAX,  VA  22030
Correspondent Contact GRETA M HOLS
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/02/2007
Decision Date 05/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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