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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 K082838
Device Name ORLUS MINI SCREW
Applicant
Ortholution Co., Ltd.
5536 Trowbridge Dr.
Dunwoody,  GA  30338
Applicant Contact CATHRYN CAMBRIA
Correspondent
Ortholution Co., Ltd.
5536 Trowbridge Dr.
Dunwoody,  GA  30338
Correspondent Contact CATHRYN CAMBRIA
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/26/2008
Decision Date 11/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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