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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 K202344
Device Name TiUltra Implants and Xeal Abutments
Applicant
Nobel Biocare AB
Box 5190, Se-402 26
Vastra Hamngatan 1,  SE 411 17
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare AB
Box 5190, Se-402 26
Vastra Hamngatan 1,  SE 411 17
Correspondent Contact Bernice Jim
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Codes
NHA   PNP  
Date Received08/18/2020
Decision Date 11/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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