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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 K021584
Device Name REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
Applicant
Nobel Biocare Uas, Inc.
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Applicant Contact RICHARD T ROSS
Correspondent
Nobel Biocare Uas, Inc.
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Correspondent Contact RICHARD T ROSS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/14/2002
Decision Date 06/05/2002
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
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