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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 K031345
Device Name NOBEL DIRECT, MODELS 30937, 30938
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  
Date Received04/29/2003
Decision Date 07/24/2003
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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