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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K083901
Device Name NAVI ROOT
Applicant
S-DENTI CO., LTD.
5401 S COTTONWOOD CT
GREENWOOD VILLAGE,  CO  80121
Applicant Contact Kevin Walls
Correspondent
S-DENTI CO., LTD.
5401 S COTTONWOOD CT
GREENWOOD VILLAGE,  CO  80121
Correspondent Contact Kevin Walls
Classification Product Code
LQY  
Date Received12/29/2008
Decision Date 04/15/2009
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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