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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 K030257
Device Name NOBEL PERFECT IMPLANT SYSTEM
Applicant
NOBEL BIOCARE UAS INC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Applicant Contact ELIZABETH J MASON
Correspondent
NOBEL BIOCARE UAS INC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Correspondent Contact ELIZABETH J MASON
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received01/24/2003
Decision Date 02/10/2003
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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