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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 K161435
Device Name Temporary Snap Abutment
Nobel Biocare AB
BOX 5190, SE-402 26, Vastra Hamngatan 1
Goteborg,  SE SE-411 17
Applicant Contact Charlemagne Chua
Nobel Biocare USA LLC
22715 Savi Ranch Parkway
Yorba Linda,  CA  92887
Correspondent Contact Charlemagne Chua
Regulation Number872.3630
Classification Product Code
Date Received05/24/2016
Decision Date 11/22/2016
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