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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 K101545
Device Name GENESIS IMPLANT SYSTEM
Applicant
KEYSTONE DENTAL
144 MIDDLESEX TURNPIKE
BURLINGTON,  MA  01803
Applicant Contact JOHN CAPONE
Correspondent
KEYSTONE DENTAL
144 MIDDLESEX TURNPIKE
BURLINGTON,  MA  01803
Correspondent Contact JOHN CAPONE
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/03/2010
Decision Date 10/28/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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