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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
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