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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K050641
Device Name ZYGOMA TIUNITE
Applicant
NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Applicant Contact ELIZABETH MASON
Correspondent
NOBEL BIOCARE USA LLC
22715 SAVI RANCH PARKWAY
YORBA LINDA,  CA  92887
Correspondent Contact ELIZABETH MASON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/14/2005
Decision Date 04/07/2005
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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