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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 K183069
FOIA Releasable 510(k) K183069
Device Name NobelZygoma 0°
Applicant
Nobel Biocare AB
Box 5190, Se-402 26, Vastra Hamngatan 1
Goteborg,  SE SE-411 17
Applicant Contact Charlemagne Chua
Correspondent
Nobel Biocare USA, LLC
22715 Savi Ranch Pkwy.
Yorba Linda,,  CA  92887
Correspondent Contact Charlemagne Chua
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Codes
DZI   NHA  
Date Received11/05/2018
Decision Date 12/04/2018
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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