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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 K003620
Device Name NSI HEXED AND NON-HEXED IMPLANT SYSTEM
Applicant
Nsi
10565 Lee Highway
Suite 100
Fairfax,  VA  22030
Applicant Contact GRETA M HOLS
Correspondent
Nsi
10565 Lee Highway
Suite 100
Fairfax,  VA  22030
Correspondent Contact GRETA M HOLS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/22/2000
Decision Date 09/19/2001
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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