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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 K050258
Device Name GROOVY IMPLANTS
Applicant
NOBEL BIOCARE AB
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Applicant Contact HERBERT CRANE
Correspondent
NOBEL BIOCARE AB
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Correspondent Contact HERBERT CRANE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/03/2005
Decision Date 04/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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