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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 K980460
Device Name ONPLANT ORTHODONTIC SYSTEM
Applicant
Nobel Biocare Uas, Inc.
777 Oakmont Ln., Suite 100
Westmont,  IL  60559
Applicant Contact BETSY A BROWN
Correspondent
Nobel Biocare Uas, Inc.
777 Oakmont Ln., Suite 100
Westmont,  IL  60559
Correspondent Contact BETSY A BROWN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/02/1998
Decision Date 05/05/1998
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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