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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 K033171
Device Name NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
Applicant
Northern Implants, LLC
10565 Lee Highway
Suite 100
Fairfax,  VA  22030
Applicant Contact GRETA HOLS
Correspondent
Northern Implants, LLC
10565 Lee Highway
Suite 100
Fairfax,  VA  22030
Correspondent Contact GRETA HOLS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/30/2003
Decision Date 04/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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