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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 LANE, SUITE 100
WESTMONT,  IL  60559
Applicant Contact BETSY A BROWN
Correspondent
NOBEL BIOCARE UAS INC
777 OAKMONT LANE, 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
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