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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 K000643
Device Name INPLANT ORTHODONTIC ANCHOR SYSTEM
Applicant
Nobel Biocare Uas, Inc.
22725 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Applicant Contact JEFF HAUSHEER
Correspondent
Nobel Biocare Uas, Inc.
22725 Savi Ranch Pkwy.
Yorba Linda,  CA  92887
Correspondent Contact JEFF HAUSHEER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/25/2000
Decision Date 09/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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