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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 K023113
Device Name REPLACE TIUNITE ENDOSSEOUS IMPLANT
Applicant
Nobel Biocare Uas, Inc.
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Applicant Contact HERBERT CRANE
Correspondent
Nobel Biocare Uas, Inc.
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Correspondent Contact HERBERT CRANE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/19/2002
Decision Date 09/26/2002
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
Recalls CDRH Recalls
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